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Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

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ClinicalTrials.gov Identifier: NCT00149214
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : May 13, 2009
Last Update Posted : March 21, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: pemetrexed
Drug: cyclophosphamide
Drug: doxorubicin
Drug: docetaxel
Enrollment 257
Recruitment Details  
Pre-assignment Details The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Period Title: Overall Study
Started 135 [1] 122
Completed 109 [2] 105
Not Completed 26 17
Reason Not Completed
Adverse Event             12             9
Withdrawal by Subject             4             1
Physician Decision             3             3
Sponsor Decision             0             1
Progressive Disease             7             3
[1]
One patient randomized to Pemetrexed (P) was treated with Cyclophosphamide (C).
[2]
The patient treated with Cyclophosphamide (C) was included in that arm (C) for safety analysis.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel Total
Hide Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) Total of all reporting groups
Overall Number of Baseline Participants 135 122 257
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 122 participants 257 participants
49.9  (10.2) 49.5  (9.7) 49.7  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Female
135
 100.0%
122
 100.0%
257
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Spain 36 29 65
Russian Federation 14 14 28
Germany 74 71 145
Italy 11 8 19
Eastern Cooperative Oncology Group Performance Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Grade 0 - Fully active 131 113 244
Grade 1- Ambulatory; strenuous activity restricted 1 4 5
Status Unknown 3 5 8
Estrogen and Progesterone Receptor Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
At least one positive 90 78 168
Both negative 45 44 89
Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Unknown 0 1 1
Pre-Menopausal 69 66 135
Peri-Menopausal 6 7 13
Post-Menopausal 60 48 108
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants 122 participants 257 participants
Caucasian 135 119 254
Hispanic 0 3 3
1.Primary Outcome
Title Number of Participants With a Pathological Complete Response
Hide Description pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy
Time Frame surgery after eight 21-day cycles of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description

Participants meeting the following criteria qualify for pathological tumor response:

  • Histologic diagnosis of primary operable breast cancer
  • No concurrent antitumor therapy
  • Specimen for evaluation of pathological response obtained upon surgery
  • Treatment with at least one dose of study drug of the assigned study regimen.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description:
pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Overall Number of Participants Analyzed 127 119
Measure Type: Number
Unit of Measure: participants
Pathological Complete Response 21 24
Tumor Cells Still Present 99 89
Not evaluable 7 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Comments Confidence Interval for pathological complete response in the Pemetrexed treatment arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 16.5
Confidence Interval 95%
10.5 to 24.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Comments Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 20.2
Confidence Interval 95%
13.4 to 28.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy
Hide Description The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.
Time Frame Cycles 1-4 (21-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description

Participants meeting following criteria qualify for clinical tumor response:

  • Histologic diagnosis of primary operable breast cancer
  • No concurrent antitumor therapy up to surgery
  • Presence of measurable disease as defined by RECIST.
  • Treatment with at least one dose of study drug of assigned study regimen.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description:
pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Overall Number of Participants Analyzed 131 119
Measure Type: Number
Unit of Measure: participants
Complete Response 8 9
Partial Response 45 43
Stable Disease 49 44
Progressive Disease 3 2
Unknown 17 17
Not Done 9 4
3.Secondary Outcome
Title Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy
Hide Description The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.
Time Frame Cycles 5-8 (21-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description

Participants meeting following criteria qualify for clinical tumor response:

  • Histologic diagnosis of primary operable breast cancer
  • No concurrent antitumor therapy up to surgery
  • Presence of measurable disease as defined by RECIST.
  • Treatment with at least one dose of study drug of assigned study regimen.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description:
pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Overall Number of Participants Analyzed 131 119
Measure Type: Number
Unit of Measure: participants
Complete Tumor Response 19 21
Partial Tumor Response 59 60
Stable Disease 35 24
Progressive Disease 2 1
Unknown 9 10
Not Done 7 3
4.Secondary Outcome
Title Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery
Hide Description Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.
Time Frame surgery after eight 21-day cycles of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description

Participants meeting the following criteria qualify for pathological tumor response:

  • Histologic diagnosis of primary operable breast cancer
  • No concurrent antitumor therapy
  • Specimen for evaluation of pathological response obtained upon surgery
  • Treatment with at least one dose of study drug of the assigned study regimen.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description:
pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Overall Number of Participants Analyzed 127 119
Measure Type: Number
Unit of Measure: participants
64 63
5.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.
Time Frame baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. In the Pemetrexed plus Doxorubicin, Followed by Docetaxel arm, 99 participants were censored. In the Cyclophosphamide plus Doxorubicin, Followed by Docetaxel arm, 94 participants were censored.
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description:
pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Overall Number of Participants Analyzed 135 122
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(47.96 to NA)
NA [1] 
(54.38 to NA)
[1]
The median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Hide Arm/Group Description pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8) cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
All-Cause Mortality
Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/134 (11.19%)      25/123 (20.33%)    
Blood and lymphatic system disorders     
Anaemia  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Chronic lymphocytic leukaemia  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Febrile neutropenia  1  4/134 (2.99%)  5 5/123 (4.07%)  6
Leukopenia  1  4/134 (2.99%)  4 9/123 (7.32%)  9
Neutropenia  1  1/134 (0.75%)  1 3/123 (2.44%)  3
Cardiac disorders     
Cardiovascular insufficiency  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Myocardial infarction  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/134 (0.75%)  2 1/123 (0.81%)  1
Nausea  1  2/134 (1.49%)  2 0/123 (0.00%)  0
Stomatitis  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Vomiting  1  3/134 (2.24%)  4 0/123 (0.00%)  0
General disorders     
Fatigue  1  0/134 (0.00%)  0 2/123 (1.63%)  2
General physical health deterioration  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Inflammation  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Injection site extravasation  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Mucosal inflammation  1  0/134 (0.00%)  0 2/123 (1.63%)  2
Pyrexia  1  3/134 (2.24%)  3 5/123 (4.07%)  5
Hepatobiliary disorders     
Hepatic function abnormal  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Hyperbilirubinaemia  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Infections and infestations     
Appendicitis  1  0/134 (0.00%)  0 2/123 (1.63%)  2
Febrile infection  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Infection  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Pharyngitis  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Pneumonia  1  1/134 (0.75%)  1 1/123 (0.81%)  1
Pneumonia primary atypical  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Pyelonephritis  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Sinusitis  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Vulvitis  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Investigations     
C-reactive protein increased  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases to central nervous system  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Nervous system disorders     
Dizziness  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Syncope  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Vascular encephalopathy  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Psychiatric disorders     
Anxiety  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Major depression  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Mood altered  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Renal and urinary disorders     
Nephritis  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Vascular disorders     
Axillary vein thrombosis  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Hypotension  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Hypovolaemic shock  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Peripheral vascular disorder  1  1/134 (0.75%)  1 0/123 (0.00%)  0
Post procedural haematoma  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Subclavian vein thrombosis  1  0/134 (0.00%)  0 1/123 (0.81%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed Plus Doxorubicin, Followed by Docetaxel Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   134/134 (100.00%)      120/123 (97.56%)    
Blood and lymphatic system disorders     
Anaemia  1  10/134 (7.46%)  17 11/123 (8.94%)  19
Leukocytosis  1  13/134 (9.70%)  29 9/123 (7.32%)  18
Leukopenia  1  66/134 (49.25%)  229 67/123 (54.47%)  252
Lymphopenia  1  19/134 (14.18%)  53 18/123 (14.63%)  50
Neutropenia  1  65/134 (48.51%)  223 73/123 (59.35%)  244
Neutrophilia  1  7/134 (5.22%)  14 4/123 (3.25%)  7
Thrombocythaemia  1  9/134 (6.72%)  12 5/123 (4.07%)  5
Thrombocytopenia  1  8/134 (5.97%)  18 12/123 (9.76%)  22
Eye disorders     
Conjunctivitis  1  19/134 (14.18%)  32 10/123 (8.13%)  14
Lacrimation increased  1  16/134 (11.94%)  20 14/123 (11.38%)  15
Gastrointestinal disorders     
Abdominal pain  1  16/134 (11.94%)  18 12/123 (9.76%)  17
Abdominal pain upper  1  21/134 (15.67%)  24 11/123 (8.94%)  12
Constipation  1  49/134 (36.57%)  81 35/123 (28.46%)  51
Diarrhoea  1  33/134 (24.63%)  50 27/123 (21.95%)  42
Dyspepsia  1  10/134 (7.46%)  11 9/123 (7.32%)  9
Nausea  1  82/134 (61.19%)  207 81/123 (65.85%)  210
Stomatitis  1  53/134 (39.55%)  95 47/123 (38.21%)  90
Vomiting  1  30/134 (22.39%)  43 40/123 (32.52%)  69
General disorders     
Asthenia  1  34/134 (25.37%)  90 28/123 (22.76%)  75
Chills  1  9/134 (6.72%)  9 11/123 (8.94%)  11
Fatigue  1  49/134 (36.57%)  100 45/123 (36.59%)  106
Mucosal inflammation  1  27/134 (20.15%)  47 18/123 (14.63%)  24
Pain  1  8/134 (5.97%)  9 8/123 (6.50%)  8
Pyrexia  1  21/134 (15.67%)  30 21/123 (17.07%)  28
Infections and infestations     
Nasopharyngitis  1  6/134 (4.48%)  6 9/123 (7.32%)  9
Investigations     
Alanine aminotransferase  1  22/134 (16.42%)  30 7/123 (5.69%)  10
Alanine aminotransferase increased  1  57/134 (42.54%)  87 33/123 (26.83%)  40
Aspartate aminotransferase  1  22/134 (16.42%)  29 7/123 (5.69%)  7
Aspartate aminotransferase increased  1  54/134 (40.30%)  80 29/123 (23.58%)  32
Blood alkaline phosphatase increased  1  5/134 (3.73%)  5 7/123 (5.69%)  11
Blood glucose increased  1  11/134 (8.21%)  25 6/123 (4.88%)  13
Blood lactate dehydrogenase increased  1  26/134 (19.40%)  33 15/123 (12.20%)  23
Gamma-glutamyltransferase increased  1  8/134 (5.97%)  11 7/123 (5.69%)  8
Haemoglobin  1  9/134 (6.72%)  11 6/123 (4.88%)  7
Haemoglobin decreased  1  32/134 (23.88%)  83 38/123 (30.89%)  86
Neutrophil count  1  9/134 (6.72%)  21 4/123 (3.25%)  9
Neutrophil count decreased  1  15/134 (11.19%)  38 9/123 (7.32%)  21
Neutrophil count increased  1  10/134 (7.46%)  22 12/123 (9.76%)  23
Platelet count increased  1  8/134 (5.97%)  11 5/123 (4.07%)  6
Red blood cell count decreased  1  7/134 (5.22%)  9 4/123 (3.25%)  7
White blood cell count  1  10/134 (7.46%)  18 6/123 (4.88%)  15
White blood cell count decreased  1  13/134 (9.70%)  28 8/123 (6.50%)  19
White blood cell count increased  1  12/134 (8.96%)  23 12/123 (9.76%)  22
Metabolism and nutrition disorders     
Anorexia  1  22/134 (16.42%)  34 25/123 (20.33%)  47
Fluid retention  1  20/134 (14.93%)  23 14/123 (11.38%)  16
Hyperglycaemia  1  12/134 (8.96%)  21 8/123 (6.50%)  10
Musculoskeletal and connective tissue disorders     
Arthralgia  1  26/134 (19.40%)  56 28/123 (22.76%)  59
Bone pain  1  16/134 (11.94%)  16 16/123 (13.01%)  21
Musculoskeletal pain  1  8/134 (5.97%)  14 10/123 (8.13%)  15
Myalgia  1  19/134 (14.18%)  23 21/123 (17.07%)  30
Nervous system disorders     
Dizziness  1  6/134 (4.48%)  9 8/123 (6.50%)  9
Dysgeusia  1  20/134 (14.93%)  27 26/123 (21.14%)  37
Headache  1  12/134 (8.96%)  14 20/123 (16.26%)  26
Peripheral sensory neuropathy  1  15/134 (11.19%)  25 12/123 (9.76%)  18
Polyneuropathy  1  25/134 (18.66%)  32 24/123 (19.51%)  31
Psychiatric disorders     
Insomnia  1  7/134 (5.22%)  9 3/123 (2.44%)  4
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/134 (5.22%)  10 12/123 (9.76%)  14
Dyspnoea  1  5/134 (3.73%)  5 8/123 (6.50%)  9
Skin and subcutaneous tissue disorders     
Alopecia  1  80/134 (59.70%)  88 68/123 (55.28%)  75
Dry skin  1  7/134 (5.22%)  8 9/123 (7.32%)  10
Erythema  1  19/134 (14.18%)  31 17/123 (13.82%)  29
Nail disorder  1  38/134 (28.36%)  47 35/123 (28.46%)  45
Palmar-plantar erythrodysaesthesia syndrome  1  14/134 (10.45%)  17 13/123 (10.57%)  14
Pruritus  1  11/134 (8.21%)  11 14/123 (11.38%)  16
Rash  1  14/134 (10.45%)  14 4/123 (3.25%)  6
Vascular disorders     
Hot flush  1  6/134 (4.48%)  7 12/123 (9.76%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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.
Results Point of Contact
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Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00149214    
Other Study ID Numbers: 7113
H3E-MC-S080 ( Other Identifier: Eli Lilly and Company )
First Submitted: September 2, 2005
First Posted: September 8, 2005
Results First Submitted: February 11, 2009
Results First Posted: May 13, 2009
Last Update Posted: March 21, 2012