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Trial record 35 of 35 for:    breast cancer weight gain

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)

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ClinicalTrials.gov Identifier: NCT00038467
Recruitment Status : Completed
First Posted : June 3, 2002
Results First Posted : April 10, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
International Collaborative Cancer Group (ICCG)
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: Tamoxifen
Drug: Exemestane
Enrollment 4740
Recruitment Details The publication describing study results (Coombes RC et al; N Engl J Med 350; 1119) stated that 4742 participants were enrolled in study. It was later discovered that 2 participants were randomized twice. Hence, 4740 participants were enrolled in this study.
Pre-assignment Details Main study also included 3 sub-studies only for the purpose of tolerability assessment: endometrial status, bone metabolism and quality of life (QoL). Out of 4740 enrolled participants, data for 16 participants from a center were excluded since it was considered unreliable. Results are reported for remaining 4724 participants.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Period Title: Overall Study
Started 2352 2372
Treated 2321 [1] 2337 [2]
Completed 1810 1830
Not Completed 542 542
Reason Not Completed
Adverse Event             170             145
Withdrawal by Subject             150             107
Protocol Violation             19             22
Death             22             16
Lost to Follow-up             15             10
Recurrence             109             179
Randomized, but not treated             31             35
Other             26             28
[1]
8 participants randomized to receive exemestane, received tamoxifen. Reported as per randomization.
[2]
7 participants randomized to receive tamoxifen, received exemestane. Reported as per randomization.
Arm/Group Title Exemestane Tamoxifen Total
Hide Arm/Group Description Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period. Total of all reporting groups
Overall Number of Baseline Participants 2352 2372 4724
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2352 participants 2372 participants 4724 participants
63.78  (8.12) 63.69  (8.22) 63.73  (8.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2352 participants 2372 participants 4724 participants
Female
2352
 100.0%
2372
 100.0%
4724
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
Hide Description DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 2352 2372
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of DFS
0.90
(0.89 to 0.92)
0.86
(0.85 to 0.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00003
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.58 to 0.82
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) at Month 36 Post-Randomization: Main Study
Hide Description OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants’ survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.
Time Frame Baseline up to Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 2352 2372
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of OS
0.953
(0.945 to 0.962)
0.941
(0.932 to 0.951)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15737
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.913
Confidence Interval (2-Sided) 95%
0.806 to 1.036
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Events of Second Breast Cancer in Contralateral Breast: Main Study
Hide Description Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.
Time Frame Baseline up to Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 2352 2372
Measure Type: Number
Unit of Measure: events
57 75
4.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
Hide Description BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 84 96
Mean (Standard Deviation)
Unit of Measure: percent change
Change at 6 months on-treatment: LS (n=84,96) -2.64  (2.89) -0.22  (2.55)
Change at 6 months on-treatment: TH (n=82,96) -1.31  (2.20) -0.13  (1.90)
Change at 12 months on-treatment: LS (n=82,96) -2.98  (3.30) -0.19  (3.53)
Change at 12 months on-treatment: TH (n=82,95) -2.17  (2.34) -0.39  (2.17)
Change at 24 months on-treatment: LS (n=82,92) -3.69  (4.12) -0.47  (3.38)
Change at 24 months on-treatment: TH (n=79,93) -2.81  (2.61) -0.91  (2.66)
Change at 24 months post-treatment: LS (n=74,81) -2.17  (5.09) -3.44  (4.28)
Change at 24 months post-treatment: TH (n=73,84) -3.06  (4.35) -4.15  (4.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.43
Confidence Interval (2-Sided) 95%
1.63 to 3.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.57 to 1.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.79
Confidence Interval (2-Sided) 95%
1.77 to 3.81
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.12 to 2.46
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.22
Confidence Interval (2-Sided) 95%
2.10 to 4.35
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.90
Confidence Interval (2-Sided) 95%
1.10 to 2.69
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
Hide Description BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 82 95
Mean (Standard Deviation)
Unit of Measure: percent change
Change at 6 months on-treatment: FN (n=82,94) -1.91  (3.17) -0.30  (3.75)
Change at 6 months on-treatment: FW (n=82,94) -2.02  (4.57) 0.32  (5.53)
Change at 12 months on-treatment: FN (n=82,95) -2.56  (3.26) -0.32  (3.60)
Change at 12 months on-treatment: FW (n=81,95) -3.51  (4.88) -1.30  (5.84)
Change at 24 months on-treatment: FN (n=78,89) -4.00  (3.61) -0.78  (4.85)
Change at 24 months on-treatment: FW (n=72,87) -4.75  (6.29) -1.86  (7.32)
Change at 24 months post-treatment: FN (n=61,69) -4.10  (5.57) -4.95  (6.46)
Change at 24 months post-treatment: FW (n=60,68) -6.07  (7.63) -8.60  (8.15)
6.Secondary Outcome
Title Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
Hide Description BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant’s value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 86 99
Mean (Standard Deviation)
Unit of Measure: T-score
Baseline: LS (n=86,99) -0.62  (1.12) -0.45  (1.14)
Baseline: TH (n=86,99) -0.27  (0.97) -0.12  (1.01)
Change at 6 months on-treatment: LS (n=84,96) -0.24  (0.26) -0.02  (0.23)
Change at 6 months on-treatment: TH (n=82,96) -0.10  (0.19) -0.00  (0.16)
Change at 12 months on-treatment: LS (n=82,96) -0.26  (0.30) -0.02  (0.32)
Change at 12 months on-treatment: TH (n=82,95) -0.16  (0.21) -0.03  (0.18)
Change at 24 months on-treatment: LS (n=82,92) -0.32  (0.41) -0.04  (0.31)
Change at 24 months on-treatment: TH (n=79,93) -0.21  (0.27) -0.07  (0.24)
Change at 24 months post-treatment: LS (n=74,81) -0.21  (0.47) -0.33  (0.41)
Change at 24 months post-treatment: TH (n=73,84) -0.25  (0.38) -0.34  (0.33)
7.Secondary Outcome
Title Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Hide Description Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 83 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline concentration
3 months: on-treatment (n=81, 92)
113.47
(108.74 to 118.41)
104.35
(100.03 to 108.85)
6 months: on-treatment (n=83, 95)
121.01
(107.99 to 135.60)
104.34
(99.18 to 109.76)
9 months: on-treatment (n=79, 92)
139.62
(131.65 to 148.06)
98.17
(92.95 to 103.67)
12 months: on-treatment (n=82, 96)
148.96
(139.83 to 158.68)
100.47
(94.36 to 106.97)
18 months: on-treatment (n=80, 95)
158.33
(147.97 to 169.41)
102.72
(96.18 to 109.69)
24 months: on-treatment (n=81, 90)
155.89
(145.04 to 167.56)
105.12
(98.36 to 112.35)
30 months: on-treatment (n=50, 65)
144.89
(125.83 to 166.83)
108.33
(99.51 to 117.94)
36 months: end of treatment (n=19, 31)
150.82
(127.82 to 177.97)
113.87
(101.28 to 128.03)
12 months: post-treatment (n=67, 87)
140.19
(129.98 to 151.19)
149.69
(138.34 to 161.97)
24 months: post-treatment (n=62, 77)
128.73
(114.70 to 144.48)
142.20
(129.09 to 156.64)
8.Secondary Outcome
Title Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Hide Description C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 83 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline concentration
3 months: on-treatment (n=81, 93)
144.14
(127.25 to 163.27)
99.19
(89.37 to 110.09)
6 months: on-treatment (n=83, 95)
197.47
(176.51 to 220.92)
93.67
(84.75 to 103.51)
9 months: on-treatment (n=79, 92)
226.04
(202.51 to 252.30)
94.40
(85.44 to 104.29)
12 months: on-treatment (n=81, 96)
232.69
(206.42 to 262.31)
94.59
(86.27 to 103.71)
18 months: on-treatment (n=80, 95)
199.68
(171.75 to 232.15)
90.35
(81.82 to 99.76)
24 months: on-treatment (n=81, 90)
177.80
(154.58 to 204.50)
88.80
(78.96 to 99.87)
30 months: on-treatment (n=50, 65)
179.29
(150.83 to 213.11)
91.62
(80.20 to 104.66)
36 months: end of treatment (n=19, 31)
130.00
(94.91 to 178.06)
99.34
(81.16 to 121.58)
12 months: post-treatment (n=67, 87)
110.87
(94.93 to 129.49)
136.50
(121.05 to 153.91)
24 months: post-treatment (n=62, 77)
100.34
(84.62 to 118.98)
124.03
(109.98 to 139.88)
9.Secondary Outcome
Title Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Hide Description Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 83 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline concentration
3 months, on-treatment: OC (n=81, 92)
149.49
(137.88 to 162.09)
101.02
(94.14 to 108.40)
3 months, on-treatment: PICP (n=81, 92)
117.23
(109.63 to 125.35)
102.19
(97.34 to 107.27)
6 months, on-treatment: OC (n=83, 95)
193.44
(177.49 to 210.81)
97.69
(91.78 to 103.98)
6 months, on-treatment: PICP (n=83, 95)
133.50
(125.30 to 142.23)
99.78
(95.18 to 104.61)
9 months, on-treatment: OC (n=79, 93)
230.41
(209.80 to 253.05)
92.52
(86.02 to 99.50)
9 months, on-treatment: PICP (n=79, 92)
131.73
(124.27 to 139.63)
96.52
(91.21 to 102.14)
12 months, on-treatment: OC (n=82, 96)
227.59
(208.40 to 248.56)
95.75
(88.46 to 103.65)
12 months, on-treatment: PICP (n=82, 96)
128.68
(122.22 to 135.50)
100.18
(95.23 to 105.39)
18 months, on-treatment: OC (n=80, 95)
230.72
(207.16 to 256.95)
93.98
(87.54 to 100.90)
18 months, on-treatment: PICP (n=80, 95)
125.40
(116.86 to 134.56)
103.25
(97.38 to 109.47)
24 months, on-treatment: OC (n=81, 90)
190.18
(171.07 to 211.41)
89.29
(82.19 to 97.00)
24 months: on-treatment: PICP (n=81, 90)
123.75
(115.11 to 133.05)
103.94
(97.75 to 110.52)
30 months, on-treatment: OC (n=50, 65)
187.23
(165.02 to 212.43)
87.34
(79.64 to 95.79)
30 months, on-treatment: PICP (n=50, 65)
113.76
(102.05 to 126.82)
103.36
(94.57 to 112.97)
36 months, end of treatment: OC (n=19, 30)
167.03
(121.37 to 229.86)
90.77
(76.63 to 107.52)
36 months, end of treatment: PICP (n=19, 31)
95.33
(79.82 to 113.84)
87.22
(76.34 to 99.66)
12 months, post-treatment: OC (n=67, 87)
143.85
(125.83 to 164.44)
152.32
(135.49 to 171.24)
12 months, post-treatment: PICP (n=67, 87)
91.53
(84.27 to 99.42)
108.67
(100.59 to 117.39)
24 months, post-treatment: OC (n=62, 77)
130.78
(114.03 to 150.00)
146.36
(128.87 to 166.22)
24 months, post-treatment: PICP (n=62, 77)
90.46
(81.68 to 100.19)
100.74
(92.95 to 109.19)
10.Secondary Outcome
Title Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Hide Description Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 83 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline concentration
3 months: on-treatment (n=82, 91)
130.49
(121.56 to 140.07)
106.99
(99.66 to 114.85)
6 months: on-treatment (n=83, 95)
145.13
(133.61 to 157.64)
103.42
(96.64 to 110.68)
9 months: on-treatment (n=80, 92)
160.12
(147.40 to 173.93)
101.08
(94.85 to 107.72)
12 months: on-treatment (n=82, 97)
155.53
(143.40 to 168.70)
104.51
(98.23 to 111.19)
18 months: on-treatment (n=77, 96)
139.57
(129.65 to 150.25)
99.25
(93.11 to 105.78)
24 months: on-treatment (n=78, 90)
135.30
(125.10 to 146.33)
99.11
(92.56 to 106.12)
30 months: on-treatment (n=49, 63)
121.39
(108.66 to 135.62)
95.97
(87.65 to 105.07)
36 months: end of treatment (n=19, 31)
107.64
(89.11 to 130.02)
101.04
(86.77 to 117.65)
12 months: post-treatment (n=65, 84)
117.94
(107.07 to 129.92)
128.47
(118.34 to 139.46)
24 months: post-treatment (n=61, 77)
105.50
(96.08 to 115.84)
120.84
(112.37 to 129.96)
11.Secondary Outcome
Title Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Hide Description N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 83 97
Geometric Mean (95% Confidence Interval)
Unit of Measure: percentage of baseline concentration
3 months: on-treatment (n=82, 91)
128.35
(118.11 to 139.48)
101.92
(94.39 to 110.05)
6 months: on-treatment (n=83, 95)
153.67
(141.89 to 166.44)
100.64
(92.92 to 109.00)
9 months: on-treatment (n=80, 92)
168.15
(152.93 to 184.90)
101.44
(92.13 to 111.68)
12 months: on-treatment (n=82, 97)
177.58
(160.20 to 196.85)
104.42
(96.57 to 112.91)
18 months: on-treatment (n=77, 96)
171.46
(153.32 to 191.75)
98.74
(89.88 to 108.46)
24 months: on-treatment (n=78, 90)
167.87
(148.36 to 189.95)
104.55
(93.40 to 117.03)
30 months: on-treatment (n=49, 63)
168.52
(144.54 to 196.48)
96.51
(83.74 to 111.22)
36 months: end of treatment (n=19, 31)
152.13
(112.43 to 205.87)
105.58
(84.56 to 131.83)
12 months: post-treatment (n=65, 84)
121.00
(101.05 to 144.88)
158.12
(139.47 to 179.26)
24 months: post-treatment (n=61, 77)
108.18
(108.18 to 129.77)
143.98
(124.26 to 166.83)
12.Secondary Outcome
Title Number of Participants With Fracture: Bone Metabolism Sub-study
Hide Description [Not Specified]
Time Frame Baseline up to 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 101 105
Measure Type: Number
Unit of Measure: participants
7 10
13.Secondary Outcome
Title Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy – Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0=‘Not at all’ to 4=‘Very much’. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 251 251
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=251, 251) -0.61  (7.72) -0.16  (7.24)
Change at 6 months (n=244, 243) -2.10  (9.66) -0.01  (7.96)
Change at 9 months (n=242, 235) -1.18  (8.62) 0.17  (8.10)
Change at 12 months (n=230, 238) -0.40  (8.03) -0.66  (8.49)
Change at 18 months (n=232, 227) -0.95  (8.99) -0.11  (8.32)
Change at 24 months (n=221, 213) -0.57  (9.06) 0.54  (8.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-1.76 to 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.10
Confidence Interval (2-Sided) 95%
-3.67 to -0.52
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.35
Confidence Interval (2-Sided) 95%
-2.86 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-1.24 to 1.77
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.84
Confidence Interval (2-Sided) 95%
-2.43 to 0.75
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.11
Confidence Interval (2-Sided) 95%
-2.76 to 0.54
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy – Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 254 253
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=254, 253) 0.04  (6.67) 0.70  (6.40)
Change at 6 months (n=245, 243) 0.17  (7.26) 0.96  (6.54)
Change at 9 months (n=243, 238) 1.10  (6.54) 1.32  (6.29)
Change at 12 months (n=233, 236) 1.98  (6.72) 1.15  (7.08)
Change at 18 months (n=235, 226) 1.25  (7.52) 1.41  (6.67)
Change at 24 months (n=222, 214) 1.93  (7.26) 1.51  (6.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-1.80 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-2.02 to 0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.698
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-1.38 to 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
-0.42 to 2.09
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.813
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-1.46 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-0.91 to 1.75
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Total Functional Assessment of Cancer Therapy – General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 252 252
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=252, 252) -0.91  (17.41) -0.38  (16.17)
Change at 6 months (n=244, 243) -3.12  (17.84) -0.04  (16.21)
Change at 9 months (n=243, 236) -1.28  (15.09) -0.38  (17.99)
Change at 12 months (n=229, 236) 0.38  (18.91) -0.53  (14.71)
Change at 18 months (n=232, 225) -0.67  (17.37) 0.06  (16.26)
Change at 24 months (n=220, 212) -1.48  (22.44) 1.43  (16.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.727
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-3.46 to 2.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.08
Confidence Interval (2-Sided) 95%
-6.12 to -0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.553
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.90
Confidence Interval (2-Sided) 95%
-3.88 to 2.08
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.563
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
-2.17 to 3.99
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.643
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-3.83 to 2.36
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.91
Confidence Interval (2-Sided) 95%
-6.63 to 0.82
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 253 252
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=253, 252) -0.32  (3.05) -0.02  (2.98)
Change at 6 months(n=246, 244) -1.08  (4.16) 0.13  (2.88)
Change at 9 months (n=242, 237) -0.37  (3.16) 0.06  (3.16)
Change at 12 months (n=233, 238) -0.26  (2.90) -0.12  (3.30)
Change at 18 months(n=234, 228) -0.19  (3.09) 0.02  (2.81)
Change at 24 months (n=223, 214) -0.005  (0.208) 0.22  (0.214)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.83 to 0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-1.84 to -0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.00 to 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.70 to 0.43
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.75 to 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.454
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.81 to 0.36
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 252 249
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=252, 249) -0.25  (3.90) -0.37  (3.59)
Change at 6 months (n=245, 241) -0.43  (3.84) -0.47  (4.01)
Change at 9 months (n=242, 235) -0.58  (3.61) -0.53  (4.22)
Change at 12 months (n=231, 235) 0.05  (4.03) -0.56  (3.87)
Change at 18 months(n=234, 226) -0.5  (3.62) -0.69  (4.31)
Change at 24 months (n=219, 212) -0.99  (4.96) -0.72  (4.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.712
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.53 to 0.335
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.65 to 0.356
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.882
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.76 to 0.359
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.54 to 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-1.16 to 0.454
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy
Hide Description The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=254, 250) 0.07  (1.20) 0.08  (0.94)
Change at 6 months (n=244, 240) -0.02  (1.34) -0.04  (1.14)
Change at 9 months (n=243, 235) -0.06  (1.12) -0.07  (1.06)
Change at 12 months (n=233, 233) -0.01  (1.20) -0.07  (1.12)
Change at 18 months (n=233, 222) -0.03  (1.27) -0.21  (1.20)
Change at 24 months (n=221, 213) -0.005  (1.25) -0.12  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.892
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.20 to 0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.21 to 0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.18 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.604
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.16 to 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.05 to 0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.11 to 0.34
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 255 252
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=255, 252) 0.06  (2.84) -0.01  (2.77)
Change at 6 months (n=246, 243) -0.32  (2.88) -0.1  (3.10)
Change at 9 months (n=243, 236) -0.47  (3.05) -0.27  (3.12)
Change at 12 months (n=232, 235) -0.03  (2.55) -0.33  (2.86)
Change at 18 months (n=235, 226) -0.3  (3.05) -0.04  (3.26)
Change at 24 months (n=222, 214) -0.18  (3.05) 0.07  (3.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.42 to 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.76 to 0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.484
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.75 to 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.19 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.26
Confidence Interval (2-Sided) 95%
-0.84 to 0.32
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.82 to 0.33
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 254 253
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=254, 253) -0.32  (3.79) -0.18  (3.32)
Change at 6 months (n=246, 244) -0.77  (4.31) -0.43  (4.01)
Change at 9 months (n=243, 238) -1.03  (3.96) -0.38  (3.62)
Change at 12 months (n=232, 238) -0.68  (4.07) -0.91  (4.38)
Change at 18 months (n=232, 227) -0.83  (4.14) -0.8  (3.89)
Change at 24 months (n=222, 214) -0.91  (4.49) -0.45  (3.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.77 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.366
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-1.08 to 0.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.65
Confidence Interval (2-Sided) 95%
-1.33 to 0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.545
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.53 to 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.932
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.77 to 0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-1.24 to 0.32
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Hide Description The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 255 252
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at 3 months (n=255, 252) 0.05  (3.76) -0.003  (3.96)
Change at 6 months (n=246, 244) -0.33  (4.17) 0.17  (4.31)
Change at 9 months (n=243, 239) 0.3  (3.99) 0.48  (4.22)
Change at 12 months (n=233, 238) 0.61  (4.08) 0.38  (4.12)
Change at 18 months (n=233, 227) 0.06  (4.61) 0.67  (4.35)
Change at 24 months (n=222, 214) 0.36  (4.33) 0.72  (4.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 3 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.876
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.62 to 0.73
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-1.25 to 0.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 9 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.630
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.92 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.530
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.50 to 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 18 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.43 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value was estimated using 2-sided t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-1.18 to 0.46
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Number of Participants With Severe Endocrine Symptoms: QoL Sub-study
Hide Description Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories “quite a bit” and “very much”) were presented.
Time Frame Baseline up to 24 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 289 293
Measure Type: Number
Unit of Measure: participants
Hot flushes 151 146
Cold sweats 60 52
Night sweats 115 117
Sleeping difficulties 110 110
Lack of energy 115 108
Nervous feeling 68 65
Lightheaded/dizzy 34 37
Headaches 56 49
Mood swings 70 66
Feeling irritable 53 48
Nausea 16 14
Gained weight 150 152
Vomiting 6 6
Diarrhea 20 21
Bloated feeling 75 88
Vaginal discharge 36 55
Vaginal irritation 37 45
Vaginal bleeding 10 11
Vaginal dryness 78 88
Discomfort with intercourse 47 45
Lost interest in sex 128 142
Breast tenderness 66 76
Pain 66 60
Feeling ill 24 24
Side effects 54 57
23.Secondary Outcome
Title Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study
Hide Description Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 61 52
Measure Type: Number
Unit of Measure: percentage of participants
6 months (n=58, 49) 46.6 69.4
12 months (n=60, 52) 30.0 55.8
24 months (n=61, 52) 36.1 63.5
36 months (n=32, 17) 21.9 76.5
6 months post-treatment (n=16, 17) 31.3 70.6
12 months post-treatment (n=50, 37) 30.0 32.4
24 months post-treatment (n=41, 31) 34.1 29.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 6 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0059
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 12 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8084
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exemestane, Tamoxifen
Comments 24 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6449
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
24.Secondary Outcome
Title Endometrial Thickness: Endometrial Sub-study
Hide Description Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 60 52
Median (Full Range)
Unit of Measure: mm
Baseline (n=60, 52)
6.0
(1.0 to 29.0)
6.0
(1.0 to 29.0)
6 months (n=58, 49)
4.0
(1.0 to 16.0)
5.9
(2.0 to 23.0)
12 months (n=59, 52)
3.3
(1.0 to 20.4)
5.5
(2.0 to 39.0)
24 months (n=60, 52)
4.0
(1.0 to 19.0)
5.0
(1.0 to 26.0)
36 months (n=31, 17)
3.0
(1.0 to 12.0)
7.0
(2.0 to 24.0)
6 months post-treatment (n=16, 17)
3.0
(1.0 to 16.6)
5.8
(4.0 to 17.0)
12 months post-treatment (n=49, 37)
3.0
(1.0 to 17.0)
4.0
(1.0 to 16.0)
24 months post-treatment (n=40, 31)
3.0
(1.0 to 21.0)
3.8
(1.0 to 10.0)
25.Secondary Outcome
Title Uterine and Overall Ovary Volume: Endometrial Sub-study
Hide Description Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Time Frame 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 57 51
Median (Full Range)
Unit of Measure: cubic centimeter (cm^3)
UV: 6 months (n=57, 47)
25.2
(5.6 to 180.0)
36.5
(4.1 to 149.8)
OV: 6 months (n=8, 6)
1.8
(1.2 to 9.7)
1.2
(0.6 to 4.2)
UV: 12 months (n=56, 49)
23.3
(0.0 to 58.3)
39.2
(6.7 to 214.2)
OV: 12 months (n=6, 5)
2.3
(1.1 to 6.6)
2.2
(0.7 to 3.8)
UV: 24 months (n=54, 51)
26.3
(6.3 to 73.9)
40.3
(4.3 to 148.9)
OV: 24 months (n=5, 6)
2.0
(0.6 to 4.2)
2.7
(1.4 to 12.4)
UV: 36 months (n=30, 18)
21.5
(4.6 to 116.5)
36.8
(6.8 to 143.3)
OV: 36 months (n=3, 2)
1.5
(0.6 to 2.3)
2.5
(1.8 to 3.2)
UV: 6 months post-treatment (n=14, 16)
25.6
(10.5 to 82.9)
31.6
(12.9 to 149.5)
OV: 6 months post-treatment (n=2, 4)
10.1
(1.4 to 18.7)
4.7
(2.8 to 11.4)
UV: 12 months post-treatment (n=42, 35)
21.7
(8.8 to 96.1)
30.0
(6.6 to 91.1)
OV: 12 months post-treatment (n=5, 4)
2.8
(1.4 to 3.9)
2.9
(2.1 to 5.3)
UV: 24 months post-treatment (n=38, 28)
22.6
(4.8 to 47.2)
27.8
(7.5 to 71.1)
OV: 24 months post-treatment (n=4, 4)
1.6
(1.0 to 3.3)
3.4
(2.1 to 4.2)
26.Secondary Outcome
Title Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study
Hide Description Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of ‘yes’, ‘no’ or ‘missing’ (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.
Time Frame 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 61 52
Measure Type: Number
Unit of Measure: participants
FIB: 6 months, BL Yes (n=60,50) 4 6
FIB: 6 months, BL No (n=60,50) 2 1
FIB: 6 months, BL Missing (n=60,50) 2 0
POL: 6 months, BL Yes (n=60,50) 0 0
POL: 6 months, BL No (n=60,50) 2 0
POL: 6 months, BL Missing (n=60,50) 1 0
FIB: 12 months, BL Yes (n=61,52) 3 7
FIB: 12 months, BL No (n=61,52) 2 1
FIB: 12 months, BL Missing (n=61,52) 4 1
POL: 12 months, BL Yes (n=61,52) 0 0
POL: 12 months, BL No (n=61,52) 0 0
POL: 12 months, BL Missing (n=61,52) 1 0
FIB: 24 months, BL Yes (n=61,52) 3 5
FIB: 24 months, BL No (n=61,52) 3 0
FIB: 24 months, BL Missing (n=61,52) 0 2
POL: 24 months, BL Yes (n=61,52) 1 0
POL: 24 months, BL No (n=61,52) 0 1
POL: 24 months, BL Missing (n=61,52) 0 0
FIB: 36 months, BL Yes (n=33,18) 2 1
FIB: 36 months, BL No (n=33,18) 3 0
FIB: 36 months, BL Missing (n=33,18) 0 0
POL: 36 months, BL Yes (n=33,18) 0 0
POL: 36 months, BL No (n=33,18) 1 0
POL: 36 months, BL Missing (n=33,18) 0 0
FIB: 6 months post-treatment, BL Yes (n=16,17) 1 0
FIB: 6 months post-treatment, BL No (n=16,17) 1 0
FIB: 6 months post-treatment,BL Missing(n=16,17) 0 2
POL: 6 months post-treatment, BL Yes (n=16,17) 0 0
POL: 6 months post-treatment, BL No (n=16,17) 0 0
POL: 6 months post-treatment,BL Missing(n=16,17) 1 0
FIB: 12 months post-treatment, BL Yes (n=51,38) 1 1
FIB: 12 months post-treatment, BL No (n=51,38) 2 0
FIB: 12 months post-treatment, BL Missing(n=51,38) 1 1
POL: 12 months post-treatment, BL Yes (n=51,38) 0 0
POL: 12 months post-treatment, BL No (n=51,38) 0 0
POL: 12 months post-treatment, BL Missing (n=51,38 0 2
FIB: 24 months post-treatment, BL Yes (n=43,31) 2 2
FIB: 24 months post-treatment, BL No (n=43,31) 2 1
FIB: 24 months post-treatment, BL Missing(n=43,31) 1 2
POL: 24 months post-treatment, BL Yes (n=43,31) 0 0
POL: 24 months post-treatment, BL No (n=43,31) 1 0
POL: 24 months post-treatment, BL Missing(n=43,31) 2 1
27.Secondary Outcome
Title Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study
Hide Description Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.
Time Frame Baseline up to 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 86 94
Measure Type: Number
Unit of Measure: percentage of participants
16.28 21.28
28.Secondary Outcome
Title Number of Participants With Histological Findings: Endometrial Sub-study
Hide Description [Not Specified]
Time Frame Baseline up to 24 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Results were not reported for this outcome measure because no data was collected as per change in planned analysis.
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description:
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description SAEs, AEs collected in separate databases.For SAE:treated population included all randomized participants with at least 1 study drug administration as per actual treatment received.For AE:safety population included all participants in treated population with at least 1 on-treatment AE assessment.AEs included AEs and illnesses reported during study.
 
Arm/Group Title Exemestane Tamoxifen
Hide Arm/Group Description Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period. Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
All-Cause Mortality
Exemestane Tamoxifen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exemestane Tamoxifen
Affected / at Risk (%) Affected / at Risk (%)
Total   383/2320 (16.51%)   439/2338 (18.78%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/2320 (0.09%)  4/2338 (0.17%) 
Disseminated intravascular coagulation * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Granulocytopenia * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Hypofibrinogenaemia * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Iron deficiency anaemia * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Lymphadenitis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Lymphadenopathy * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Thrombocytopenia * 1  1/2320 (0.04%)  5/2338 (0.21%) 
Cardiac disorders     
Acute myocardial infarction * 1  5/2320 (0.22%)  0/2338 (0.00%) 
Adams-Stokes syndrome * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Angina pectoris * 1  4/2320 (0.17%)  4/2338 (0.17%) 
Angina unstable * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Arrhythmia * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Atrial fibrillation * 1  7/2320 (0.30%)  8/2338 (0.34%) 
Atrial flutter * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Cardiac arrest * 1  0/2320 (0.00%)  2/2338 (0.09%) 
Cardiac disorder * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Cardiac failure * 1  6/2320 (0.26%)  2/2338 (0.09%) 
Cardiac failure congestive * 1  5/2320 (0.22%)  3/2338 (0.13%) 
Cardiac valve disease * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Coronary artery disease * 1  3/2320 (0.13%)  2/2338 (0.09%) 
Cyanosis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Left ventricular failure * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Mitral valve incompetence * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Myocardial infarction * 1  9/2320 (0.39%)  5/2338 (0.21%) 
Myocardial ischaemia * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Tachyarrhythmia * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Tachycardia paroxysmal * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Ventricular fibrillation * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Congenital, familial and genetic disorders     
Porphyria non-acute * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Ear and labyrinth disorders     
Auricular perichondritis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Deafness * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Deafness unilateral * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Ear disorder * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Tinnitus * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Vertigo * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Endocrine disorders     
Endocrine disorder * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Goitre * 1  4/2320 (0.17%)  1/2338 (0.04%) 
Hypothyroidism * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Thyroiditis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Eye disorders     
Cataract * 1  3/2320 (0.13%)  2/2338 (0.09%) 
Eyelid ptosis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Optic ischaemic neuropathy * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Retinal detachment * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Retinal vein thrombosis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Retinopathy * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Strabismus * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Visual acuity reduced * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Abdominal pain * 1  12/2320 (0.52%)  6/2338 (0.26%) 
Abdominal pain upper * 1  1/2320 (0.04%)  2/2338 (0.09%) 
Abdominal strangulated hernia * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Ascites * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Constipation * 1  1/2320 (0.04%)  3/2338 (0.13%) 
Diarrhoea * 1  5/2320 (0.22%)  1/2338 (0.04%) 
Diverticulitis oesophageal * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Diverticulum intestinal * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Dyspepsia * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Enterocele * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Enterocolitis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Faeces discoloured * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Gastric ulcer * 1  3/2320 (0.13%)  0/2338 (0.00%) 
Gastritis * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Gastritis erosive * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Ileus * 1  0/2320 (0.00%)  5/2338 (0.21%) 
Inguinal hernia * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Intestinal obstruction * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Melaena * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Nausea * 1  4/2320 (0.17%)  1/2338 (0.04%) 
Pancreatitis * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Pancreatitis acute * 1  4/2320 (0.17%)  0/2338 (0.00%) 
Rectal haemorrhage * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Rectal ulcer * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Salivary gland calculus * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Small intestinal obstruction * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Swollen tongue * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Umbilical hernia, obstructive * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Volvulus * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Vomiting * 1  6/2320 (0.26%)  2/2338 (0.09%) 
General disorders     
Asthenia * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Axillary pain * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Chest pain * 1  5/2320 (0.22%)  4/2338 (0.17%) 
Condition aggravated * 1  17/2320 (0.73%)  14/2338 (0.60%) 
Death * 1  3/2320 (0.13%)  1/2338 (0.04%) 
Device failure * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Disease progression * 1  4/2320 (0.17%)  10/2338 (0.43%) 
Disease recurrence * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Fatigue * 1  3/2320 (0.13%)  1/2338 (0.04%) 
Gait disturbance * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Granuloma * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Hernia * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Hyperplasia * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Local swelling * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Multi-organ failure * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Non-cardiac chest pain * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Oedema * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Oedema peripheral * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Pain * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Pelvic mass * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Pyrexia * 1  1/2320 (0.04%)  4/2338 (0.17%) 
Sudden death * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Biliary colic * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Cholangitis * 1  1/2320 (0.04%)  2/2338 (0.09%) 
Cholecystitis * 1  2/2320 (0.09%)  3/2338 (0.13%) 
Cholecystitis acute * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Cholelithiasis * 1  7/2320 (0.30%)  9/2338 (0.38%) 
Gallbladder disorder * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Hepatic pain * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Jaundice * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  2/2320 (0.09%)  2/2338 (0.09%) 
Infections and infestations     
Abdominal hernia gangrenous * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Abscess * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Appendicitis * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Breast cellulitis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Bronchitis * 1  2/2320 (0.09%)  3/2338 (0.13%) 
Bronchopneumonia * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Cellulitis * 1  1/2320 (0.04%)  5/2338 (0.21%) 
Cellulitis laryngeal * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Cystitis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Device related infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Diverticulitis * 1  3/2320 (0.13%)  1/2338 (0.04%) 
Ear infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Endocarditis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Endometritis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Erysipelas * 1  2/2320 (0.09%)  4/2338 (0.17%) 
Gastroenteritis * 1  0/2320 (0.00%)  4/2338 (0.17%) 
Herpes zoster * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Infection * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Infective exacerbation of chronic obstructive airways disease * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Lobar pneumonia * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Localised infection * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Lung infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Lymphangitis * 1  1/2320 (0.04%)  2/2338 (0.09%) 
Mastitis * 1  2/2320 (0.09%)  0/2338 (0.00%) 
Osteomyelitis * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Otitis media * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Pneumonia * 1  10/2320 (0.43%)  4/2338 (0.17%) 
Pyelonephritis * 1  1/2320 (0.04%)  2/2338 (0.09%) 
Pyelonephritis acute * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Sepsis * 1  0/2320 (0.00%)  3/2338 (0.13%) 
Septic shock * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Skin infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Streptococcal sepsis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Upper respiratory tract infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Urinary tract infection * 1  1/2320 (0.04%)  4/2338 (0.17%) 
Urosepsis * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Viral infection * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture * 1  2/2320 (0.09%)  4/2338 (0.17%) 
Back injury * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Clavicle fracture * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Extradural haematoma * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Fall * 1  2/2320 (0.09%)  6/2338 (0.26%) 
Femoral neck fracture * 1  3/2320 (0.13%)  3/2338 (0.13%) 
Femur fracture * 1  3/2320 (0.13%)  2/2338 (0.09%) 
Forearm fracture * 1  0/2320 (0.00%)  2/2338 (0.09%) 
Fracture * 1  7/2320 (0.30%)  8/2338 (0.34%) 
Head injury * 1  0/2320 (0.00%)  3/2338 (0.13%) 
Hip fracture * 1  4/2320 (0.17%)  2/2338 (0.09%) 
Humerus fracture * 1  2/2320 (0.09%)  1/2338 (0.04%) 
Incisional hernia * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Injury * 1  1/2320 (0.04%)  2/2338 (0.09%) 
Joint dislocation * 1  1/2320 (0.04%)  3/2338 (0.13%) 
Joint injury * 1  1/2320 (0.04%)  0/2338 (0.00%) 
Ligament injury * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Limb injury * 1  0/2320 (0.00%)  1/2338 (0.04%) 
Meniscus injury * 1  1/2320 (0.04%)  1/2338 (0.04%) 
Multiple fractures * 1  0/2320 (0.00%)  4/2338 (0.17%) 
Patella fracture