Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01386684
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : April 2, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
JSS Medical Research Inc.
CMX Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Prostate Cancer
Enrollment 552
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description Patients with prostate cancer who were receiving treatment with Lupron.
Period Title: Overall Study
Started 552
Completed 259
Not Completed 293
Reason Not Completed
Lost to Follow-up             51
Not Specified             51
Death             47
Withdrawal of Consent             44
Alternative Therapy Required             37
Disease Progression             28
Adverse Event             20
Noncompliance             8
Protocol Violation             4
Missing             3
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Baseline Participants 552
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 552 participants
76.3  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 552 participants
Female
0
   0.0%
Male
552
 100.0%
1.Primary Outcome
Title Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0
Hide Description PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Error)
Unit of Measure: months
20.76  (0.59)
2.Primary Outcome
Title Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests
Hide Description A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Error)
Unit of Measure: months
21.89  (0.69)
3.Secondary Outcome
Title Castration Resistant Prostate Cancer (CRPC): Number of Participants
Hide Description CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved PSA levels ≤ 2 ng/mL
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 440
Measure Type: Number
Unit of Measure: participants
84
4.Secondary Outcome
Title Castration Resistant Prostate Cancer (CRPC): Time to Event
Hide Description CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved PSA levels ≤2 ng/mL
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 440
Mean (Standard Error)
Unit of Measure: months
26.01  (0.42)
5.Secondary Outcome
Title Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit
Hide Description Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point.
Time Frame Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: percentage of participants
Month 0: ≤ 0.7 nmol/L Number Analyzed 190 participants
16.3
Month 3: ≤ 0.7 nmol/L Number Analyzed 245 participants
65.3
Month 6: ≤ 0.7 nmol/L Number Analyzed 229 participants
62.9
Month 12: ≤ 0.7 nmol/L Number Analyzed 208 participants
68.8
Month 18: ≤ 0.7 nmol/L Number Analyzed 187 participants
69.0
Month 24: ≤ 0.7 nmol/L Number Analyzed 160 participants
68.8
Month 30: ≤ 0.7 nmol/L Number Analyzed 133 participants
69.2
Month 36: ≤ 0.7 nmol/L Number Analyzed 122 participants
55.7
Month 0: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 190 participants
6.3
Month 3: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 245 participants
32.7
Month 6: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 229 participants
31.4
Month 12: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 208 participants
18.8
Month 18: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 187 participants
15.5
Month 24: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 160 participants
12.5
Month 30: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 133 participants
12.8
Month 36: > 0.7 to ≤ 1.7 nmol/L Number Analyzed 122 participants
15.6
Month 0: > 1.7 nmol/L Number Analyzed 190 participants
77.4
Month 3: > 1.7 nmol/L Number Analyzed 245 participants
2.0
Month 6: > 1.7 nmol/L Number Analyzed 229 participants
5.7
Month 12: > 1.7 nmol/L Number Analyzed 208 participants
12.5
Month 18: > 1.7 nmol/L Number Analyzed 187 participants
15.5
Month 24: > 1.7 nmol/L Number Analyzed 160 participants
18.8
Month 30: > 1.7 nmol/L Number Analyzed 133 participants
18.0
Month 36: > 1.7 nmol/L Number Analyzed 122 participants
28.7
6.Secondary Outcome
Title Total Serum Testosterone Levels at Each Visit
Hide Description Total serum testosterone was assessed at each study visit.
Time Frame Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: nmol/L
Month 0 Number Analyzed 190 participants
10.9  (8.90)
Month 3 Number Analyzed 245 participants
0.6  (0.98)
Month 6 Number Analyzed 229 participants
1.0  (2.32)
Month 12 Number Analyzed 208 participants
1.5  (3.29)
Month 18 Number Analyzed 187 participants
1.9  (4.05)
Month 24 Number Analyzed 160 participants
2.1  (4.31)
Month 30 Number Analyzed 133 participants
2.3  (4.81)
Month 36 Number Analyzed 122 participants
2.9  (4.69)
7.Secondary Outcome
Title Total Serum Testosterone: Time to Increase Over Castrate Levels
Hide Description Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who achieved castrate testosterone levels (≤1.7 nmol/L)
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 359
Mean (Standard Error)
Unit of Measure: months
31.20  (0.67)
8.Secondary Outcome
Title Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit
Hide Description Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point.
Time Frame Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available date at given time point
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Number
Unit of Measure: percentage of participants
Month 0: <1 ng/mL Number Analyzed 545 participants
15.2
Month 3: <1 ng/mL Number Analyzed 440 participants
55.9
Month 6: <1 ng/mL Number Analyzed 432 participants
61.8
Month 12: <1 ng/mL Number Analyzed 387 participants
63.6
Month 18: <1 ng/mL Number Analyzed 336 participants
64.6
Month 24: <1 ng/mL Number Analyzed 280 participants
60.7
Month 30: <1 ng/mL Number Analyzed 253 participants
56.9
Month 36: <1 ng/mL Number Analyzed 233 participants
57.5
Month 0: 1 to <5 ng/mL Number Analyzed 545 participants
17.4
Month 3: 1 to <5 ng/mL Number Analyzed 440 participants
31.4
Month 6: 1 to <5 ng/mL Number Analyzed 432 participants
21.5
Month 12: 1 to <5 ng/mL Number Analyzed 387 participants
16.8
Month 18: 1 to <5 ng/mL Number Analyzed 336 participants
17.9
Month 24: 1 to <5 ng/mL Number Analyzed 280 participants
16.4
Month 30: 1 to <5 ng/mL Number Analyzed 253 participants
19.8
Month 36: 1 to <5 ng/mL Number Analyzed 233 participants
18.9
Month 0: 5 to <10 ng/mL Number Analyzed 545 participants
17.6
Month 3: 5 to <10 ng/mL Number Analyzed 440 participants
4.1
Month 6: 5 to <10 ng/mL Number Analyzed 432 participants
7.6
Month 12: 5 to <10 ng/mL Number Analyzed 387 participants
7.5
Month 18: 5 to <10 ng/mL Number Analyzed 336 participants
8.9
Month 24: 5 to <10 ng/mL Number Analyzed 280 participants
6.8
Month 30: 5 to <10 ng/mL Number Analyzed 253 participants
7.5
Month 36: 5 to <10 ng/mL Number Analyzed 233 participants
9.0
Month 0: ≥10 ng/mL Number Analyzed 545 participants
49.7
Month 3: ≥10 ng/mL Number Analyzed 440 participants
8.6
Month 6: ≥10 ng/mL Number Analyzed 432 participants
9.0
Month 12: ≥10 ng/mL Number Analyzed 387 participants
12.1
Month 18: ≥10 ng/mL Number Analyzed 336 participants
8.6
Month 24: ≥10 ng/mL Number Analyzed 280 participants
16.1
Month 30: ≥10 ng/mL Number Analyzed 253 participants
15.8
Month 36: ≥10 ng/mL Number Analyzed 233 participants
14.6
9.Secondary Outcome
Title Prostatic Specific Antigen (PSA) Levels at Each Visit
Hide Description Serum PSA was assessed at each study visit.
Time Frame Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: ng/ml
Month 0 Number Analyzed 545 participants
65.0  (377.60)
Month 3 Number Analyzed 440 participants
6.5  (41.33)
Month 6 Number Analyzed 432 participants
12.0  (80.64)
Month 12 Number Analyzed 387 participants
19.1  (128.51)
Month 18 Number Analyzed 336 participants
13.3  (113.98)
Month 24 Number Analyzed 280 participants
11.2  (56.69)
Month 30 Number Analyzed 253 participants
13.5  (65.79)
Month 36 Number Analyzed 233 participants
8.2  (37.12)
10.Secondary Outcome
Title Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Error)
Unit of Measure: units on a scale
Month 3 -0.9  (0.6)
Month 6 -2.2  (0.6)
Month 12 -1.7  (0.6)
Month 18 -1.0  (0.7)
Month 24 -1.4  (0.7)
Month 30 -1.3  (0.7)
Month 36 -1.9  (0.8)
11.Secondary Outcome
Title Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Error)
Unit of Measure: units on a scale
Month 3 -1.1  (0.8)
Month 6 -2.8  (0.8)
Month 12 -2.4  (0.9)
Month 18 -1.8  (0.9)
Month 24 -2.1  (0.9)
Month 30 -2.3  (1.0)
Month 36 -3.0  (1.0)
12.Secondary Outcome
Title International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit
Hide Description IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.
Time Frame Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Error)
Unit of Measure: units on a scale
Month 6 -2.7  (0.3)
Month 12 -3.2  (0.3)
Month 18 -3.3  (0.3)
Month 24 -3.7  (0.3)
Month 30 -3.5  (0.3)
Month 36 -3.3  (0.3)
13.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 452
Month 3 408
Month 6 384
Month 12 328
Month 18 279
Month 24 258
Month 30 220
Month 36 196
14.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 38
Month 3 44
Month 6 38
Month 12 34
Month 18 20
Month 24 23
Month 30 14
Month 36 8
15.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had visited a physician and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: physician visits
Month 0 Number Analyzed 15 participants
1.2  (0.56)
Month 3 Number Analyzed 19 participants
1.5  (0.84)
Month 6 Number Analyzed 19 participants
7.1  (13.93)
Month 12 Number Analyzed 17 participants
1.6  (1.17)
Month 18 Number Analyzed 6 participants
2.7  (1.86)
Month 24 Number Analyzed 5 participants
2.4  (1.14)
Month 30 Number Analyzed 3 participants
2.0  (1.00)
Month 36 Number Analyzed 3 participants
2.0  (0.00)
16.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 20
Month 3 23
Month 6 20
Month 12 21
Month 18 8
Month 24 11
Month 30 9
Month 36 3
17.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had visited a healthcare professional and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: healthcare professional visits
Month 0 Number Analyzed 11 participants
7.8  (14.05)
Month 3 Number Analyzed 11 participants
3.5  (4.11)
Month 6 Number Analyzed 11 participants
18.5  (19.06)
Month 12 Number Analyzed 11 participants
3.1  (2.12)
Month 18 Number Analyzed 4 participants
2.3  (0.96)
Month 24 Number Analyzed 3 participants
1.7  (1.15)
Month 30 Number Analyzed 5 participants
1.6  (0.89)
Month 36 Number Analyzed 0 participants
18.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 9
Month 3 7
Month 6 3
Month 12 8
Month 18 5
Month 24 6
Month 30 4
Month 36 2
19.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had visited a hospital emergency room and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: hospital emergency room visits
Month 0 Number Analyzed 5 participants
1.2  (0.45)
Month 3 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 6 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 12 Number Analyzed 5 participants
1.4  (0.55)
Month 18 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 24 Number Analyzed 0 participants
Month 30 Number Analyzed 2 participants
1.0  (0.00)
Month 36 Number Analyzed 0 participants
[1]
The estimated standard deviation of one sample is undefined
20.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 4
Month 3 2
Month 6 4
Month 12 2
Month 18 2
Month 24 3
Month 30 2
Month 36 1
21.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had used an ambulance service and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: ambulance service uses
Month 0 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 3 Number Analyzed 0 participants
Month 6 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 12 Number Analyzed 0 participants
Month 18 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 24 Number Analyzed 0 participants
Month 30 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 36 Number Analyzed 0 participants
[1]
The estimated standard deviation of one sample is undefined
22.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 3
Month 3 2
Month 6 1
Month 12 4
Month 18 3
Month 24 0
Month 30 0
Month 36 1
23.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had visited complementary/alternate therapy and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: complementary/alternate therapy visits
Month 0 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 3 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 6 Number Analyzed 0 participants
Month 12 Number Analyzed 2 participants
3.5  (2.12)
Month 18 Number Analyzed 0 participants
Month 24 Number Analyzed 0 participants
Month 30 Number Analyzed 0 participants
Month 36 Number Analyzed 0 participants
[1]
The estimated standard deviation of one sample is undefined
24.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 9
Month 3 8
Month 6 12
Month 12 9
Month 18 5
Month 24 6
Month 30 2
Month 36 2
25.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had visited for any other medical service and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: visits for any other medical service
Month 0 Number Analyzed 5 participants
7.4  (12.66)
Month 3 Number Analyzed 4 participants
2.0  (2.00)
Month 6 Number Analyzed 1 participants
1.0 [1]   (NA)
Month 12 Number Analyzed 2 participants
1.0  (0.00)
Month 18 Number Analyzed 0 participants
Month 24 Number Analyzed 0 participants
Month 30 Number Analyzed 0 participants
Month 36 Number Analyzed 1 participants
1.0 [1]   (NA)
[1]
The estimated standard deviation of one sample is undefined
26.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Measure Type: Count of Participants
Unit of Measure: Participants
Month 0 29
Month 3 14
Month 6 9
Month 12 14
Month 18 9
Month 24 5
Month 30 4
Month 36 8
27.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were admitted to the hospital and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: admissions to the hospital
Month 0 Number Analyzed 29 participants
1.0  (0.00)
Month 3 Number Analyzed 14 participants
1.0  (0.00)
Month 6 Number Analyzed 9 participants
1.0  (0.00)
Month 12 Number Analyzed 14 participants
1.0  (0.00)
Month 18 Number Analyzed 9 participants
1.0  (0.00)
Month 24 Number Analyzed 5 participants
1.0  (0.00)
Month 30 Number Analyzed 4 participants
1.0  (0.00)
Month 36 Number Analyzed 8 participants
1.0  (0.00)
28.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for over-the-counter medications and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 368 participants
21.5  (73.50)
Month 3 Number Analyzed 327 participants
19.3  (101.66)
Month 6 Number Analyzed 298 participants
25.5  (130.41)
Month 12 Number Analyzed 254 participants
26.6  (101.28)
Month 18 Number Analyzed 223 participants
20.9  (80.53)
Month 24 Number Analyzed 197 participants
13.9  (60.01)
Month 30 Number Analyzed 167 participants
13.4  (54.69)
Month 36 Number Analyzed 152 participants
13.1  (55.12)
29.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for payments to health care professionals and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 330 participants
0.9  (11.66)
Month 3 Number Analyzed 305 participants
2.5  (30.24)
Month 6 Number Analyzed 275 participants
2.5  (31.18)
Month 12 Number Analyzed 244 participants
0.8  (12.80)
Month 18 Number Analyzed 208 participants
2.4  (34.67)
Month 24 Number Analyzed 190 participants
2.6  (36.27)
Month 30 Number Analyzed 157 participants
1.6  (19.95)
Month 36 Number Analyzed 149 participants
7.9  (62.50)
30.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for medical procedures and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 337 participants
14.0  (91.76)
Month 3 Number Analyzed 304 participants
2.6  (22.01)
Month 6 Number Analyzed 278 participants
4.1  (33.59)
Month 12 Number Analyzed 246 participants
3.0  (20.96)
Month 18 Number Analyzed 211 participants
2.7  (18.39)
Month 24 Number Analyzed 189 participants
6.8  (54.35)
Month 30 Number Analyzed 158 participants
5.2  (35.89)
Month 36 Number Analyzed 149 participants
2.9  (20.11)
31.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 337 participants
14.0  (91.76)
Month 3 Number Analyzed 304 participants
2.6  (22.01)
Month 6 Number Analyzed 278 participants
4.1  (33.59)
Month 12 Number Analyzed 246 participants
3.0  (20.96)
Month 18 Number Analyzed 211 participants
2.7  (18.39)
Month 24 Number Analyzed 189 participants
6.8  (54.35)
Month 30 Number Analyzed 158 participants
5.2  (35.89)
Month 36 Number Analyzed 149 participants
2.9  (20.11)
32.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for medical devices and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 333 participants
4.0  (40.46)
Month 3 Number Analyzed 307 participants
7.5  (58.00)
Month 6 Number Analyzed 274 participants
21.0  (292.53)
Month 12 Number Analyzed 245 participants
7.3  (96.50)
Month 18 Number Analyzed 210 participants
2.1  (16.79)
Month 24 Number Analyzed 193 participants
2.4  (22.88)
Month 30 Number Analyzed 158 participants
1.5  (12.96)
Month 36 Number Analyzed 148 participants
2.0  (24.66)
33.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for health care or extra help at home and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 332 participants
4.9  (58.06)
Month 3 Number Analyzed 305 participants
4.9  (60.31)
Month 6 Number Analyzed 273 participants
14.7  (189.44)
Month 12 Number Analyzed 242 participants
28.9  (390.75)
Month 18 Number Analyzed 210 participants
0.4  (6.21)
Month 24 Number Analyzed 190 participants
1.4  (14.26)
Month 30 Number Analyzed 157 participants
3.0  (24.16)
Month 36 Number Analyzed 148 participants
11.8  (92.40)
34.Secondary Outcome
Title Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer
Hide Description The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.
Time Frame Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with out of pocket expenses for transportation costs and with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: dollars (CAD)
Month 0 Number Analyzed 336 participants
20.0  (124.86)
Month 3 Number Analyzed 312 participants
19.5  (77.92)
Month 6 Number Analyzed 278 participants
23.0  (96.03)
Month 12 Number Analyzed 249 participants
9.2  (27.87)
Month 18 Number Analyzed 214 participants
6.3  (19.88)
Month 24 Number Analyzed 194 participants
10.6  (87.22)
Month 30 Number Analyzed 163 participants
8.2  (26.54)
Month 36 Number Analyzed 149 participants
2.7  (9.30)
35.Secondary Outcome
Title Treatment Compliance
Hide Description Treatment compliance by participants was assessed as the number of missed injections since the last visit.
Time Frame Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: missed injections
Month 3 Number Analyzed 519 participants
0.0  (0.12)
Month 6 Number Analyzed 486 participants
0.0  (0.17)
Month 12 Number Analyzed 425 participants
0.1  (0.35)
Month 18 Number Analyzed 364 participants
0.2  (0.53)
Month 24 Number Analyzed 315 participants
0.2  (0.66)
Month 30 Number Analyzed 285 participants
0.2  (0.57)
Month 36 Number Analyzed 258 participants
0.2  (0.83)
36.Secondary Outcome
Title Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.
Hide Description Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented.
Time Frame Months 3, 6, 12, 18, 24, 30, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants with changes in current prostate cancer treatment since the last visit at given time point.
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description:
Patients with prostate cancer who were receiving treatment with Lupron.
Overall Number of Participants Analyzed 522
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 Initiation or Change in Dose/Frequency Number Analyzed 117 participants
9.4
Month 3 Discontinuation of Medication Number Analyzed 117 participants
90.6
Month 6 Initiation or Change in Dose/Frequency Number Analyzed 47 participants
42.6
Month 6 Discontinuation of Medication Number Analyzed 47 participants
57.4
Month 12 Initiation or Change in Dose/Frequency Number Analyzed 37 participants
54.1
Month 12 Discontinuation of Medication Number Analyzed 522 participants
45.9
Month 18 Initiation or Change in Dose/Frequency Number Analyzed 20 participants
45.0
Month 18 Discontinuation of Medication Number Analyzed 20 participants
45.0
Month 24 Initiation or Change in Dose/Frequency Number Analyzed 25 participants
60.0
Month 24 Discontinuation of Medication Number Analyzed 25 participants
40.0
Month 30 Initiation or Change in Dose/Frequency Number Analyzed 21 participants
71.4
Month 30 Discontinuation of Medication Number Analyzed 21 participants
28.6
Month 36 Initiation or Change in Dose/Frequency Number Analyzed 14 participants
57.1
Month 36 Discontinuation of Medication Number Analyzed 14 participants
42.9
Time Frame Spontaneously-reported adverse events (AEs) and serious adverse events (SAEs) were collected from the time that informed consent was given until 30 days following the last dose of physician-prescribed treatment (up to 37 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Prostate Cancer
Hide Arm/Group Description Patients with prostate cancer who were receiving treatment with Lupron.
All-Cause Mortality
Patients With Prostate Cancer
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Prostate Cancer
Affected / at Risk (%)
Total   132/552 (23.91%) 
Blood and lymphatic system disorders   
ANAEMIA * 1  5/552 (0.91%) 
BANDAEMIA * 1  1/552 (0.18%) 
LYMPHADENOPATHY * 1  1/552 (0.18%) 
NEUTROPENIA * 1  1/552 (0.18%) 
THROMBOCYTOPENIA * 1  1/552 (0.18%) 
Cardiac disorders   
ACUTE CORONARY SYNDROME * 1  4/552 (0.72%) 
ANGINA PECTORIS * 1  1/552 (0.18%) 
ANGINA UNSTABLE * 1  1/552 (0.18%) 
AORTIC VALVE STENOSIS * 1  1/552 (0.18%) 
ARRHYTHMIA * 1  2/552 (0.36%) 
ATRIAL FIBRILLATION * 1  8/552 (1.45%) 
BUNDLE BRANCH BLOCK RIGHT * 1  2/552 (0.36%) 
CARDIAC ARREST * 1  2/552 (0.36%) 
CARDIAC DISORDER * 1  2/552 (0.36%) 
CARDIAC FAILURE * 1  2/552 (0.36%) 
CARDIAC FAILURE CONGESTIVE * 1  9/552 (1.63%) 
CARDIOMEGALY * 1  2/552 (0.36%) 
CORONARY ARTERY DISEASE * 1  3/552 (0.54%) 
ISCHAEMIC CARDIOMYOPATHY * 1  1/552 (0.18%) 
LEFT VENTRICULAR HYPERTROPHY * 1  1/552 (0.18%) 
MITRAL VALVE INCOMPETENCE * 1  1/552 (0.18%) 
MYOCARDIAL INFARCTION * 1  8/552 (1.45%) 
MYOCARDIAL ISCHAEMIA * 1  2/552 (0.36%) 
PALPITATIONS * 1  1/552 (0.18%) 
SINUS BRADYCARDIA * 1  1/552 (0.18%) 
TACHYCARDIA * 1  3/552 (0.54%) 
Ear and labyrinth disorders   
DEAFNESS * 1  1/552 (0.18%) 
VERTIGO * 1  1/552 (0.18%) 
Eye disorders   
DIPLOPIA * 1  1/552 (0.18%) 
OCULAR MYASTHENIA * 1  1/552 (0.18%) 
Gastrointestinal disorders   
ABDOMINAL MASS * 1  1/552 (0.18%) 
ABDOMINAL PAIN * 1  6/552 (1.09%) 
COELIAC DISEASE * 1  1/552 (0.18%) 
COLITIS ISCHAEMIC * 1  1/552 (0.18%) 
CONSTIPATION * 1  1/552 (0.18%) 
DIARRHOEA HAEMORRHAGIC * 1  1/552 (0.18%) 
DIVERTICULUM * 1  1/552 (0.18%) 
EPIGASTRIC DISCOMFORT * 1  1/552 (0.18%) 
GASTRIC ULCER * 1  1/552 (0.18%) 
GASTROINTESTINAL HAEMORRHAGE * 1  3/552 (0.54%) 
HAEMATEMESIS * 1  1/552 (0.18%) 
HIATUS HERNIA * 1  1/552 (0.18%) 
INTESTINAL MASS * 1  1/552 (0.18%) 
INTESTINAL OBSTRUCTION * 1  1/552 (0.18%) 
IRRITABLE BOWEL SYNDROME * 1  1/552 (0.18%) 
LARGE INTESTINAL OBSTRUCTION * 1  1/552 (0.18%) 
NAUSEA * 1  2/552 (0.36%) 
NEUTROPENIC COLITIS * 1  1/552 (0.18%) 
RECTAL HAEMORRHAGE * 1  1/552 (0.18%) 
VOMITING * 1  2/552 (0.36%) 
General disorders   
ASTHENIA * 1  7/552 (1.27%) 
CHEST PAIN * 1  3/552 (0.54%) 
CHILLS * 1  1/552 (0.18%) 
CONDITION AGGRAVATED * 1  1/552 (0.18%) 
DEATH * 1  7/552 (1.27%) 
DISEASE PROGRESSION * 1  7/552 (1.27%) 
DRUG INEFFECTIVE * 1  1/552 (0.18%) 
FATIGUE * 1  4/552 (0.72%) 
GAIT DISTURBANCE * 1  1/552 (0.18%) 
GENERAL PHYSICAL HEALTH DETERIORATION * 1  4/552 (0.72%) 
IMPAIRED SELF-CARE * 1  1/552 (0.18%) 
INFLAMMATION * 1  1/552 (0.18%) 
LOCAL SWELLING * 1  1/552 (0.18%) 
MALAISE * 1  2/552 (0.36%) 
NO THERAPEUTIC RESPONSE * 1  1/552 (0.18%) 
OBSTRUCTION * 1  2/552 (0.36%) 
OEDEMA PERIPHERAL * 1  2/552 (0.36%) 
PAIN * 1  4/552 (0.72%) 
PELVIC MASS * 1  1/552 (0.18%) 
PYREXIA * 1  5/552 (0.91%) 
UNEVALUABLE EVENT * 1  1/552 (0.18%) 
Hepatobiliary disorders   
HEPATIC LESION * 1  1/552 (0.18%) 
Immune system disorders   
IMMUNOSUPPRESSION * 1  1/552 (0.18%) 
Infections and infestations   
DEVICE RELATED INFECTION * 1  1/552 (0.18%) 
ENDOCARDITIS BACTERIAL * 1  1/552 (0.18%) 
ESCHERICHIA INFECTION * 1  1/552 (0.18%) 
GASTROENTERITIS * 1  1/552 (0.18%) 
GASTROENTERITIS ESCHERICHIA COLI * 1  1/552 (0.18%) 
INFECTION * 1  1/552 (0.18%) 
INFLUENZA * 1  1/552 (0.18%) 
PNEUMONIA * 1  5/552 (0.91%) 
PYELONEPHRITIS ACUTE * 1  1/552 (0.18%) 
SEPSIS * 1  3/552 (0.54%) 
SEPTIC SHOCK * 1  1/552 (0.18%) 
STAPHYLOCOCCAL BACTERAEMIA * 1  1/552 (0.18%) 
STAPHYLOCOCCAL INFECTION * 1  1/552 (0.18%) 
STAPHYLOCOCCAL SEPSIS * 1  1/552 (0.18%) 
URINARY TRACT INFECTION * 1  3/552 (0.54%) 
UROSEPSIS * 1  3/552 (0.54%) 
Injury, poisoning and procedural complications   
ANAESTHETIC COMPLICATION * 1  1/552 (0.18%) 
CERVICAL VERTEBRAL FRACTURE * 1  2/552 (0.36%) 
FALL * 1  11/552 (1.99%) 
FEMORAL NECK FRACTURE * 1  1/552 (0.18%) 
FIBULA FRACTURE * 1  1/552 (0.18%) 
HEAD INJURY * 1  1/552 (0.18%) 
HIP FRACTURE * 1  4/552 (0.72%) 
JOINT DISLOCATION * 1  1/552 (0.18%) 
OVERDOSE * 1  1/552 (0.18%) 
PELVIC FRACTURE * 1  1/552 (0.18%) 
POST PROCEDURAL HAEMORRHAGE * 1  2/552 (0.36%) 
RIB FRACTURE * 1  1/552 (0.18%) 
SPINAL COMPRESSION FRACTURE * 1  1/552 (0.18%) 
SPINAL FRACTURE * 1  1/552 (0.18%) 
TIBIA FRACTURE * 1  1/552 (0.18%) 
TRACHEOSTOMY MALFUNCTION * 1  1/552 (0.18%) 
TRAUMATIC LUNG INJURY * 1  1/552 (0.18%) 
UPPER LIMB FRACTURE * 1  2/552 (0.36%) 
URINARY RETENTION POSTOPERATIVE * 1  1/552 (0.18%) 
WRIST FRACTURE * 1  1/552 (0.18%) 
Investigations   
BLOOD ALBUMIN DECREASED * 1  1/552 (0.18%) 
BLOOD CREATININE INCREASED * 1  2/552 (0.36%) 
BLOOD URINE PRESENT * 1  1/552 (0.18%) 
BRAIN NATRIURETIC PEPTIDE INCREASED * 1  1/552 (0.18%) 
EJECTION FRACTION ABNORMAL * 1  1/552 (0.18%) 
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION * 1  2/552 (0.36%) 
EXERCISE ELECTROCARDIOGRAM ABNORMAL * 1  1/552 (0.18%) 
HAEMOGLOBIN DECREASED * 1  1/552 (0.18%) 
OXYGEN SATURATION DECREASED * 1  2/552 (0.36%) 
PROSTATIC SPECIFIC ANTIGEN INCREASED * 1  1/552 (0.18%) 
SCAN MYOCARDIAL PERFUSION ABNORMAL * 1  2/552 (0.36%) 
STAPHYLOCOCCUS TEST POSITIVE * 1  1/552 (0.18%) 
TROPONIN INCREASED * 1  1/552 (0.18%) 
VENOUS PRESSURE JUGULAR INCREASED * 1  1/552 (0.18%) 
WEIGHT DECREASED * 1  2/552 (0.36%) 
WHITE BLOOD CELL COUNT DECREASED * 1  1/552 (0.18%) 
WHITE BLOOD CELL COUNT INCREASED * 1  1/552 (0.18%) 
Metabolism and nutrition disorders   
ACIDOSIS * 1  1/552 (0.18%) 
DECREASED APPETITE * 1  2/552 (0.36%) 
DEHYDRATION * 1  2/552 (0.36%) 
DIABETES MELLITUS * 1  2/552 (0.36%) 
FAILURE TO THRIVE * 1  2/552 (0.36%) 
HYPERCALCAEMIA * 1  1/552 (0.18%) 
HYPERGLYCAEMIA * 1  2/552 (0.36%) 
HYPERKALAEMIA * 1  1/552 (0.18%) 
HYPOCALCAEMIA * 1  1/552 (0.18%) 
HYPOGLYCAEMIA * 1  2/552 (0.36%) 
HYPOKALAEMIA * 1  2/552 (0.36%) 
HYPONATRAEMIA * 1  2/552 (0.36%) 
HYPOPHOSPHATAEMIA * 1  1/552 (0.18%) 
HYPOVOLAEMIA * 1  1/552 (0.18%) 
MALNUTRITION * 1  1/552 (0.18%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  2/552 (0.36%) 
BACK PAIN * 1  3/552 (0.54%) 
BONE PAIN * 1  1/552 (0.18%) 
JOINT SWELLING * 1  1/552 (0.18%) 
MOBILITY DECREASED * 1  1/552 (0.18%) 
OSTEOARTHRITIS * 1  2/552 (0.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BILIARY NEOPLASM * 1  1/552 (0.18%) 
BLADDER CANCER * 1  1/552 (0.18%) 
BLADDER TRANSITIONAL CELL CARCINOMA * 1  1/552 (0.18%) 
CANCER PAIN * 1  1/552 (0.18%) 
CHOLESTEATOMA * 1  1/552 (0.18%) 
CHRONIC LYMPHOCYTIC LEUKAEMIA * 1  1/552 (0.18%) 
COLON CANCER * 1  4/552 (0.72%) 
COLON CANCER METASTATIC * 1  1/552 (0.18%) 
COLON NEOPLASM * 1  1/552 (0.18%) 
GASTROINTESTINAL STROMAL TUMOUR * 1  1/552 (0.18%) 
HIGH GRADE B-CELL LYMPHOMA BURKITT-LIKE LYMPHOMA * 1  1/552 (0.18%) 
HORMONE-REFRACTORY PROSTATE CANCER * 1  3/552 (0.54%) 
LUNG ADENOCARCINOMA STAGE I * 1  1/552 (0.18%) 
LUNG NEOPLASM MALIGNANT * 1  2/552 (0.36%) 
MESOTHELIOMA * 1  1/552 (0.18%) 
METASTASES TO BONE * 1  10/552 (1.81%) 
METASTASES TO LIVER * 1  3/552 (0.54%) 
METASTASES TO LUNG * 1  1/552 (0.18%) 
METASTASES TO RECTUM * 1  1/552 (0.18%) 
METASTASIS * 1  1/552 (0.18%) 
METASTATIC NEOPLASM * 1  1/552 (0.18%) 
NEOPLASM PROGRESSION * 1  1/552 (0.18%) 
PLASMA CELL MYELOMA * 1  1/552 (0.18%) 
PROSTATE CANCER * 1  10/552 (1.81%) 
PROSTATE CANCER METASTATIC * 1  14/552 (2.54%) 
PROSTATE CANCER STAGE IV * 1  1/552 (0.18%) 
SQUAMOUS CELL CARCINOMA OF PHARYNX * 1  1/552 (0.18%) 
Nervous system disorders   
BALANCE DISORDER * 1  2/552 (0.36%) 
CAUDA EQUINA SYNDROME * 1  1/552 (0.18%) 
CEREBROVASCULAR ACCIDENT * 1  2/552 (0.36%) 
COMA * 1  1/552 (0.18%) 
DEMENTIA * 1  1/552 (0.18%) 
DIZZINESS * 1  3/552 (0.54%) 
HEADACHE * 1  2/552 (0.36%) 
LOSS OF CONSCIOUSNESS * 1  2/552 (0.36%) 
SEIZURE * 1  1/552 (0.18%) 
SYNCOPE * 1  4/552 (0.72%) 
UNRESPONSIVE TO STIMULI * 1  1/552 (0.18%) 
Product Issues   
DEVICE OCCLUSION * 1  1/552 (0.18%) 
Psychiatric disorders   
ANXIETY * 1  1/552 (0.18%) 
CONFUSIONAL STATE * 1  3/552 (0.54%) 
DELIRIUM * 1  3/552 (0.54%) 
DELUSION * 1  1/552 (0.18%) 
DISORIENTATION * 1  1/552 (0.18%) 
PARANOIA * 1  1/552 (0.18%) 
Renal and urinary disorders   
ACUTE KIDNEY INJURY * 1  6/552 (1.09%) 
CALCULUS BLADDER * 1  2/552 (0.36%) 
DYSURIA * 1  4/552 (0.72%) 
HAEMATURIA * 1  4/552 (0.72%) 
INCONTINENCE * 1  1/552 (0.18%) 
INTERCAPILLARY GLOMERULOSCLEROSIS * 1  1/552 (0.18%) 
NEPHROLITHIASIS * 1  2/552 (0.36%) 
OBSTRUCTIVE UROPATHY * 1  1/552 (0.18%) 
POLLAKIURIA * 1  1/552 (0.18%) 
RENAL CYST * 1  1/552 (0.18%) 
RENAL FAILURE * 1  4/552 (0.72%) 
URETERIC OBSTRUCTION * 1  1/552 (0.18%) 
URINARY BLADDER HAEMORRHAGE * 1  1/552 (0.18%) 
URINARY RETENTION * 1  2/552 (0.36%) 
Reproductive system and breast disorders   
BENIGN PROSTATIC HYPERPLASIA * 1  3/552 (0.54%) 
PROSTATIC OBSTRUCTION * 1  1/552 (0.18%) 
PROSTATOMEGALY * 1  1/552 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
ALVEOLITIS * 1  1/552 (0.18%) 
ASTHMA * 1  1/552 (0.18%) 
ATELECTASIS * 1  3/552 (0.54%) 
BRONCHIAL HYPERREACTIVITY * 1  1/552 (0.18%) 
BRONCHIECTASIS * 1  1/552 (0.18%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE * 1  5/552 (0.91%) 
DYSPNOEA * 1  11/552 (1.99%) 
DYSPNOEA EXERTIONAL * 1  1/552 (0.18%) 
HAEMOTHORAX * 1  1/552 (0.18%) 
HYPOXIA * 1  1/552 (0.18%) 
LUNG CONSOLIDATION * 1  1/552 (0.18%) 
LUNG DISORDER * 1  1/552 (0.18%) 
PLEURAL EFFUSION * 1  4/552 (0.72%) 
PNEUMOTHORAX * 1  1/552 (0.18%) 
PULMONARY EMBOLISM * 1  3/552 (0.54%) 
PULMONARY FIBROSIS * 1  1/552 (0.18%) 
PULMONARY OEDEMA * 1  1/552 (0.18%) 
RESPIRATORY ARREST * 1  1/552 (0.18%) 
RESPIRATORY DISTRESS * 1  1/552 (0.18%) 
RESPIRATORY FAILURE * 1  1/552 (0.18%) 
SLEEP APNOEA SYNDROME * 1  1/552 (0.18%) 
Skin and subcutaneous tissue disorders   
COLD SWEAT * 1  1/552 (0.18%) 
ERYTHEMA * 1  1/552 (0.18%) 
RASH ERYTHEMATOUS * 1  1/552 (0.18%) 
RASH MACULO-PAPULAR * 1  1/552 (0.18%) 
RASH PRURITIC * 1  1/552 (0.18%) 
Social circumstances   
ACTIVITIES OF DAILY LIVING IMPAIRED * 1  1/552 (0.18%) 
Surgical and medical procedures   
BLADDER CALCULUS REMOVAL * 1  1/552 (0.18%) 
HIP ARTHROPLASTY * 1  1/552 (0.18%) 
HYDROCELE OPERATION * 1  1/552 (0.18%) 
STERNOTOMY * 1  1/552 (0.18%) 
TRANSURETHRAL PROSTATECTOMY * 1  2/552 (0.36%) 
URINARY CYSTECTOMY * 1  1/552 (0.18%) 
Vascular disorders   
ANGIOPATHY * 1  1/552 (0.18%) 
AORTIC STENOSIS * 1  1/552 (0.18%) 
BLEEDING VARICOSE VEIN * 1  1/552 (0.18%) 
DEEP VEIN THROMBOSIS * 1  4/552 (0.72%) 
HYPERTENSION * 1  1/552 (0.18%) 
HYPOTENSION * 1  3/552 (0.54%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Prostate Cancer
Affected / at Risk (%)
Total   77/552 (13.95%) 
Blood and lymphatic system disorders   
LEUKOCYTE VACUOLISATION * 1  1/552 (0.18%) 
LYMPHADENOPATHY * 1  1/552 (0.18%) 
Cardiac disorders   
ATRIAL FIBRILLATION * 1  2/552 (0.36%) 
CORONARY ARTERY DISEASE * 1  1/552 (0.18%) 
Ear and labyrinth disorders   
EAR PAIN * 1  1/552 (0.18%) 
Eye disorders   
OCULAR MYASTHENIA * 1  1/552 (0.18%) 
Gastrointestinal disorders   
CONSTIPATION * 1  3/552 (0.54%) 
DIARRHOEA * 1  2/552 (0.36%) 
DYSPHAGIA * 1  1/552 (0.18%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  2/552 (0.36%) 
HAEMORRHOIDS * 1  1/552 (0.18%) 
NAUSEA * 1  1/552 (0.18%) 
General disorders   
ASTHENIA * 1  3/552 (0.54%) 
CHEST DISCOMFORT * 1  1/552 (0.18%) 
CHEST PAIN * 1  1/552 (0.18%) 
CHILLS * 1  2/552 (0.36%) 
DISEASE PROGRESSION * 1  1/552 (0.18%) 
DRUG INEFFECTIVE * 1  6/552 (1.09%) 
FATIGUE * 1  9/552 (1.63%) 
GAIT DISTURBANCE * 1  2/552 (0.36%) 
GENERAL PHYSICAL HEALTH DETERIORATION * 1  3/552 (0.54%) 
INJECTION SITE ERYTHEMA * 1  1/552 (0.18%) 
INJECTION SITE PAIN * 1  1/552 (0.18%) 
INJECTION SITE REACTION * 1  1/552 (0.18%) 
INJECTION SITE SWELLING * 1  1/552 (0.18%) 
INJECTION SITE ULCER * 1  1/552 (0.18%) 
MALAISE * 1  1/552 (0.18%) 
NODULE * 1  1/552 (0.18%) 
OEDEMA PERIPHERAL * 1  1/552 (0.18%) 
PAIN * 1  2/552 (0.36%) 
Hepatobiliary disorders   
HEPATIC LESION * 1  1/552 (0.18%) 
Immune system disorders   
DRUG HYPERSENSITIVITY * 1  1/552 (0.18%) 
Infections and infestations   
DYSENTERY * 1  1/552 (0.18%) 
INFECTION * 1  1/552 (0.18%) 
PNEUMONIA * 1  1/552 (0.18%) 
URINARY TRACT INFECTION * 1  2/552 (0.36%) 
URINARY TRACT INFECTION ENTEROCOCCAL * 1  1/552 (0.18%) 
Injury, poisoning and procedural complications   
FALL * 1  1/552 (0.18%) 
RADIATION ASSOCIATED PAIN * 1  1/552 (0.18%) 
SPINAL FRACTURE * 1  1/552 (0.18%) 
Investigations   
BLOOD CREATININE ABNORMAL * 1  1/552 (0.18%) 
BLOOD CREATININE INCREASED * 1  1/552 (0.18%) 
BLOOD TESTOSTERONE * 1  1/552 (0.18%) 
BLOOD TESTOSTERONE INCREASED * 1  1/552 (0.18%) 
GLYCOSYLATED HAEMOGLOBIN INCREASED * 1  1/552 (0.18%) 
HAEMOGLOBIN ABNORMAL * 1  1/552 (0.18%) 
LIVER FUNCTION TEST ABNORMAL * 1  1/552 (0.18%) 
NEUTROPHIL COUNT INCREASED * 1  1/552 (0.18%) 
NEUTROPHIL TOXIC GRANULATION PRESENT * 1  1/552 (0.18%) 
OXYGEN SATURATION DECREASED * 1  1/552 (0.18%) 
PROSTATIC SPECIFIC ANTIGEN INCREASED * 1  4/552 (0.72%) 
WEIGHT DECREASED * 1  1/552 (0.18%) 
WEIGHT INCREASED * 1  1/552 (0.18%) 
WHITE BLOOD CELL COUNT ABNORMAL * 1  1/552 (0.18%) 
WHITE BLOOD CELL COUNT INCREASED * 1  1/552 (0.18%) 
Metabolism and nutrition disorders   
CACHEXIA * 1  1/552 (0.18%) 
DECREASED APPETITE * 1  2/552 (0.36%) 
DIABETES MELLITUS * 1  1/552 (0.18%) 
DIABETES MELLITUS INADEQUATE CONTROL * 1  1/552 (0.18%) 
FLUID INTAKE REDUCED * 1  1/552 (0.18%) 
HYPERCHOLESTEROLAEMIA * 1  1/552 (0.18%) 
HYPERLIPIDAEMIA * 1  1/552 (0.18%) 
HYPOGLYCAEMIA * 1  2/552 (0.36%) 
HYPOKALAEMIA * 1  1/552 (0.18%) 
HYPONATRAEMIA * 1  1/552 (0.18%) 
HYPOPHAGIA * 1  2/552 (0.36%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  3/552 (0.54%) 
BACK PAIN * 1  1/552 (0.18%) 
BONE LESION * 1  1/552 (0.18%) 
BONE PAIN * 1  2/552 (0.36%) 
GROIN PAIN * 1  1/552 (0.18%) 
JOINT DESTRUCTION * 1  1/552 (0.18%) 
JOINT SWELLING * 1  2/552 (0.36%) 
MOBILITY DECREASED * 1  2/552 (0.36%) 
MUSCLE SPASMS * 1  1/552 (0.18%) 
MUSCULAR WEAKNESS * 1  1/552 (0.18%) 
MUSCULOSKELETAL STIFFNESS * 1  2/552 (0.36%) 
MYALGIA * 1  2/552 (0.36%) 
OSTEONECROSIS * 1  1/552 (0.18%) 
PAIN IN EXTREMITY * 1  2/552 (0.36%) 
SPINAL OSTEOARTHRITIS * 1  1/552 (0.18%) 
WEIGHT BEARING DIFFICULTY * 1  1/552 (0.18%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
LARYNGEAL CANCER * 1  1/552 (0.18%) 
LUNG NEOPLASM * 1  2/552 (0.36%) 
METASTASES TO BONE * 1  1/552 (0.18%) 
METASTATIC NEOPLASM * 1  1/552 (0.18%) 
NEOPLASM MALIGNANT * 1  1/552 (0.18%) 
PROSTATE CANCER METASTATIC * 1  1/552 (0.18%) 
RECTAL CANCER * 1  1/552 (0.18%) 
Nervous system disorders   
DEMENTIA * 1  2/552 (0.36%) 
DIZZINESS * 1  2/552 (0.36%) 
DYSGEUSIA * 1  1/552 (0.18%) 
HEADACHE * 1  1/552 (0.18%) 
HYPOAESTHESIA * 1  1/552 (0.18%) 
LETHARGY * 1  1/552 (0.18%) 
MEMORY IMPAIRMENT * 1  1/552 (0.18%) 
NEURALGIA * 1  1/552 (0.18%) 
SYNCOPE * 1  1/552 (0.18%) 
TREMOR * 1  1/552 (0.18%) 
Psychiatric disorders   
CONFUSIONAL STATE * 1  2/552 (0.36%) 
DEPRESSION * 1  1/552 (0.18%) 
EMOTIONAL DISORDER * 1  1/552 (0.18%) 
EUPHORIC MOOD * 1  1/552 (0.18%) 
LISTLESS * 1  1/552 (0.18%) 
PSYCHIATRIC DECOMPENSATION * 1  1/552 (0.18%) 
Renal and urinary disorders   
HAEMATURIA * 1  2/552 (0.36%) 
NEPHROLITHIASIS * 1  2/552 (0.36%) 
NOCTURIA * 1  1/552 (0.18%) 
RENAL FAILURE * 1  1/552 (0.18%) 
URINARY RETENTION * 1  1/552 (0.18%) 
Reproductive system and breast disorders   
PELVIC PAIN * 1  1/552 (0.18%) 
PROSTATIC OBSTRUCTION * 1  1/552 (0.18%) 
Respiratory, thoracic and mediastinal disorders   
COUGH * 1  2/552 (0.36%) 
DYSPHONIA * 1  1/552 (0.18%) 
DYSPNOEA * 1  2/552 (0.36%) 
EPISTAXIS * 1  1/552 (0.18%) 
LUNG CONSOLIDATION * 1  1/552 (0.18%) 
PULMONARY EMBOLISM * 1  1/552 (0.18%) 
RALES * 1  1/552 (0.18%) 
RHINORRHOEA * 1  1/552 (0.18%) 
SNEEZING * 1  1/552 (0.18%) 
THROAT IRRITATION * 1  1/552 (0.18%) 
Skin and subcutaneous tissue disorders   
ALOPECIA * 1  1/552 (0.18%) 
HYPERHIDROSIS * 1  1/552 (0.18%) 
NIGHT SWEATS * 1  1/552 (0.18%) 
RASH GENERALISED * 1  1/552 (0.18%) 
Social circumstances   
ACTIVITIES OF DAILY LIVING IMPAIRED * 1  2/552 (0.36%) 
Surgical and medical procedures   
RADIOTHERAPY TO PROSTATE * 1  1/552 (0.18%) 
Vascular disorders   
DEEP VEIN THROMBOSIS * 1  1/552 (0.18%) 
HAEMODYNAMIC INSTABILITY * 1  1/552 (0.18%) 
HOT FLUSH * 1  15/552 (2.72%) 
HYPOTENSION * 1  2/552 (0.36%) 
PALLOR * 1  1/552 (0.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.1)
This was a real-world evidence assessment with clear limitations. One of the key limitations of the study was that treatment patterns were not fully documented. Furthermore, compliance/adherence may have impacted efficacy data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01386684     History of Changes
Other Study ID Numbers: P12-811
First Submitted: June 30, 2011
First Posted: July 1, 2011
Results First Submitted: August 24, 2017
Results First Posted: April 2, 2018
Last Update Posted: December 13, 2018