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Trial record 27 of 54 for:    colon cancer | ( Map: Mississippi, United States )

A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00192075
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : December 23, 2009
Last Update Posted : February 7, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: Gemcitabine
Drug: avastin
Drug: 5FU/folinic acid
Drug: oxaliplatin
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Period Title: Overall Study
Started 42 42
Completed 3 23
Not Completed 39 19
Reason Not Completed
Disease Progression             23             6
Adverse Event             1             3
Death             0             1
Lack of Efficacy             0             0
Physician Decision             3             0
Withdrawal by Subject             5             5
Patient Non-Compliance             0             1
Unacceptable Toxicity Exhibited by Drug             2             1
Other             5             2
Arm/Group Title A+FFG A + FOLFOX 4 Total
Hide Arm/Group Description Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid) Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
62
(28 to 79)
64
(32 to 81)
63
(28 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
21
  50.0%
22
  52.4%
43
  51.2%
Male
21
  50.0%
20
  47.6%
41
  48.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 84 participants
42 42 84
Diagnosis to Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
<6 months 29 29 58
>=6 months 13 13 26
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
0 - Fully Active 23 20 43
1 - Ambulatory, Restricted Strenuous Activity 19 22 41
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Primary Tumor Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Colon 25 35 60
Rectum 10 4 14
Other 7 3 10
Prior Adjuvant Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Yes 12 14 26
No 30 28 58
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Caucasian 33 34 67
African descent 5 6 11
Asian 0 1 1
Hispanic 4 1 5
Site of Metastasis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Liver 28 29 57
Lung 13 11 24
Abdominal 3 3 6
Regional lymph nodes 14 14 28
Distant lymph nodes 4 3 7
Genitourinary 1 0 1
Other 8 3 11
[1]
Measure Description: Metastasis could occur in multiple sites.
Tumor Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Primary tumor 37 41 78
Regional lymph nodes 24 29 53
Distant metastasis 25 20 45
[1]
Measure Description: Patients could experience multiple tumors.
1.Primary Outcome
Title Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Time Frame baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 1 2
Partial Response (PR) 3 15
Overall Response Rate (CR+PR) 4 17
Stable Disease (SD) 21 16
Disease Control Rate (CR+PR+SD) 25 33
Progressive Disease 14 7
Unknown 3 2
2.Secondary Outcome
Title Time to Progressive Disease
Hide Description Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time Frame randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 42 42
Median (95% Confidence Interval)
Unit of Measure: months
8.6
(5.3 to 17.9)
9.7
(7.3 to 11.2)
3.Secondary Outcome
Title Progression-Free Survival
Hide Description Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Time Frame randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 42 42
Median (95% Confidence Interval)
Unit of Measure: months
8.6
(4.7 to 17.9)
9.5
(6.9 to 11.2)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 42 42
Median (95% Confidence Interval)
Unit of Measure: months
20.6
(14.8 to 26.7)
19.7
(11.2 to 32.0)
5.Secondary Outcome
Title Duration of Response
Hide Description The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time Frame date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 4 17
Median (95% Confidence Interval)
Unit of Measure: months
12.7
(5.5 to 32.9)
7.9
(4.4 to 9.8)
6.Other Pre-specified Outcome
Title Tumor Response - Avastin Subgroup
Time Frame baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Arm/Group Title A+FFG - Avastin Subgroup A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 1
Partial Response (PR) 0 8
Overall Response Rate (CR+PR) 0 9
Stable Disease (SD) 11 8
Disease Control Rate (CR+PR+SD) 11 17
Progressive Disease 6 1
Unknown 1 0
7.Other Pre-specified Outcome
Title Time to Progressive Disease - Avastin Subgroup
Hide Description Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time Frame randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.
Arm/Group Title A+FFG - Avastin Subgroup A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
Overall Number of Participants Analyzed 18 18
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(4.6 to 19.3)
13.8
(6.3 to 23.7)
8.Other Pre-specified Outcome
Title Progression-Free Survival - Avastin Subgroup
Hide Description Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Time Frame randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.
Arm/Group Title A+FFG - Avastin Subgroup A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
Overall Number of Participants Analyzed 18 18
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(4.6 to 19.3)
11.5
(6.3 to 18.1)
9.Other Pre-specified Outcome
Title Survival at 12 Months and 24 Months - Avastin Subgroup
Hide Description Percentage of participants who were alive at 12 months and 24 months.
Time Frame randomization to the date of death from any cause (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Arm/Group Title A+FFG - Avastin Subgroup A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants alive
12-Month Survival
75.6
(47.3 to 90.1)
83.3
(56.8 to 94.3)
24-Month Survival
50.4
(24.9 to 71.4)
66.7
(40.4 to 83.4)
10.Other Pre-specified Outcome
Title Toxicity - Avastin Subgroup
Hide Description Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either >=1 Grade 4 or >=2 Grade 3 adverse events
Time Frame every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Arm/Group Title A+FFG - Avastin Subgrouup A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: participants
Neutropenia (Grade 3) 3 5
Neutropenia (Grade 4) 5 1
Thrombocytopenia (Grade 3) 1 0
Thrombocytopenia (Grade 4) 0 0
Leukopenia (Grade 3) 3 0
Leukopenia (Grade 4) 1 0
Anemia (Grade 3) 0 0
Anemia (Grade 4) 0 0
Febrile neutropenia (Grade 3) 0 1
Febrile neutropenia (Grade 4) 0 0
Diarrhea (Grade 3) 1 0
Diarrhea (Grade 4) 0 1
Small intestinal obstruction (Grade 3) 1 1
Small intestinal obstruction (Grade 4) 0 0
Fatigue (Grade 3) 0 2
Fatigue (Grade 4) 0 0
Cerebral infarction (Grade 3) 0 0
Cerebral infarction (Grade 4) 0 0
Hyperglycemia (Grade 3) 0 0
Hyperglycemia (Grade 4) 0 0
Dehydration (Grade 3) 0 1
Dehydration (Grade 4) 0 0
Deep vein thrombosis (Grade 3) 0 2
Deep vein thrombosis (Grade 4) 0 0
Myocardial infarction (Grade 3) 0 0
Myocardial infarction (Grade 4) 0 2
Subdural hematoma (Grade 3) 0 0
Subdural hematoma (Grade 4) 0 0
Perirectal abscess (Grade 3) 1 0
Perirectal abscess (Grade 4) 0 0
Hypoxia (Grade 3) 0 0
Hypoxia (Grade 4) 0 0
11.Other Pre-specified Outcome
Title Duration of Response - A+FOLFOX4 - Avastin Subgroup
Hide Description The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time Frame date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.
Arm/Group Title A + FOLFOX 4 - Avastin Subgroup
Hide Arm/Group Description:
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(4.2 to 13.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A+FFG A + FOLFOX 4
Hide Arm/Group Description Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid) Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
All-Cause Mortality
A+FFG A + FOLFOX 4
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A+FFG A + FOLFOX 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/42 (26.19%)      8/42 (19.05%)    
Blood and lymphatic system disorders     
Neutropenia  1  0/42 (0.00%)  0 2/42 (4.76%)  2
Cardiac disorders     
Myocardial infarction  1  0/42 (0.00%)  0 2/42 (4.76%)  2
Palpitations  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Diarrhoea  1  1/42 (2.38%)  1 1/42 (2.38%)  1
Enteritis  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Gastrointestinal haemorrhage  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Perirectal abscess  1  1/42 (2.38%)  1 1/42 (2.38%)  1
Small intestinal obstruction  1  1/42 (2.38%)  1 2/42 (4.76%)  2
Vomiting  1  1/42 (2.38%)  1 0/42 (0.00%)  0
General disorders     
Pyrexia  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Catheter related infection  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Pelvic abscess  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Pneumonia primary atypical  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Tooth abscess  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Urinary tract infection  1  0/42 (0.00%)  0 2/42 (4.76%)  2
Injury, poisoning and procedural complications     
Subdural haematoma  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Nervous system disorders     
Cerebral infarction  1  0/42 (0.00%)  0 1/42 (2.38%)  1
Syncope vasovagal  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Psychiatric disorders     
Confusional state  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Vascular disorders     
Deep vein thrombosis  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Thrombophlebitis superficial  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Thrombosis  1  1/42 (2.38%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A+FFG A + FOLFOX 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/42 (95.24%)      41/42 (97.62%)    
Blood and lymphatic system disorders     
Anaemia  1  16/42 (38.10%)  32 4/42 (9.52%)  6
Leukopenia  1  8/42 (19.05%)  29 5/42 (11.90%)  5
Neutropenia  1  24/42 (57.14%)  76 16/42 (38.10%)  34
Thrombocytopenia  1  14/42 (33.33%)  37 8/42 (19.05%)  13
Gastrointestinal disorders     
Abdominal pain  1  9/42 (21.43%)  15 4/42 (9.52%)  5
Constipation  1  15/42 (35.71%)  39 10/42 (23.81%)  16
Diarrhoea  1  15/42 (35.71%)  30 17/42 (40.48%)  38
Dry mouth  1  3/42 (7.14%)  5 0/42 (0.00%)  0
Nausea  1  19/42 (45.24%)  39 25/42 (59.52%)  49
Stomatitis  1  9/42 (21.43%)  14 5/42 (11.90%)  5
Vomiting  1  8/42 (19.05%)  18 15/42 (35.71%)  26
General disorders     
Asthenia  1  1/42 (2.38%)  1 4/42 (9.52%)  4
Fatigue  1  22/42 (52.38%)  46 24/42 (57.14%)  48
Oedema peripheral  1  3/42 (7.14%)  5 4/42 (9.52%)  4
Pain  1  3/42 (7.14%)  4 3/42 (7.14%)  4
Pyrexia  1  10/42 (23.81%)  16 6/42 (14.29%)  6
Rigors  1  6/42 (14.29%)  9 3/42 (7.14%)  4
Infections and infestations     
Upper respiratory tract infection  1  4/42 (9.52%)  4 1/42 (2.38%)  1
Investigations     
Aspartate aminotransferase increased  1  3/42 (7.14%)  3 0/42 (0.00%)  0
Haematocrit decreased  1  5/42 (11.90%)  7 2/42 (4.76%)  4
Haemoglobin decreased  1  6/42 (14.29%)  9 4/42 (9.52%)  13
Neutrophil count decreased  1  8/42 (19.05%)  20 7/42 (16.67%)  14
Neutrophil percentage decreased  1  3/42 (7.14%)  5 2/42 (4.76%)  7
Platelet count decreased  1  5/42 (11.90%)  7 5/42 (11.90%)  7
Red blood cell count decreased  1  3/42 (7.14%)  3 1/42 (2.38%)  2
Weight decreased  1  5/42 (11.90%)  5 1/42 (2.38%)  1
White blood cell count decreased  1  8/42 (19.05%)  18 5/42 (11.90%)  7
White blood cell count increased  1  0/42 (0.00%)  0 3/42 (7.14%)  10
Metabolism and nutrition disorders     
Anorexia  1  8/42 (19.05%)  16 8/42 (19.05%)  8
Dehydration  1  1/42 (2.38%)  1 3/42 (7.14%)  3
Hyperglycaemia  1  3/42 (7.14%)  4 4/42 (9.52%)  7
Hypocalcaemia  1  2/42 (4.76%)  2 3/42 (7.14%)  7
Hypokalaemia  1  4/42 (9.52%)  4 5/42 (11.90%)  10
Hyponatraemia  1  3/42 (7.14%)  3 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/42 (16.67%)  14 2/42 (4.76%)  2
Back pain  1  9/42 (21.43%)  14 5/42 (11.90%)  5
Bone pain  1  3/42 (7.14%)  4 0/42 (0.00%)  0
Myalgia  1  6/42 (14.29%)  10 1/42 (2.38%)  1
Pain in extremity  1  2/42 (4.76%)  2 3/42 (7.14%)  3
Nervous system disorders     
Dizziness  1  3/42 (7.14%)  3 4/42 (9.52%)  4
Dysgeusia  1  5/42 (11.90%)  5 6/42 (14.29%)  7
Headache  1  10/42 (23.81%)  21 3/42 (7.14%)  4
Neuropathy  1  0/42 (0.00%)  0 9/42 (21.43%)  13
Neuropathy peripheral  1  0/42 (0.00%)  0 7/42 (16.67%)  9
Paraesthesia  1  2/42 (4.76%)  2 11/42 (26.19%)  25
Peripheral sensory neuropathy  1  0/42 (0.00%)  0 6/42 (14.29%)  21
Psychiatric disorders     
Depression  1  2/42 (4.76%)  2 4/42 (9.52%)  4
Insomnia  1  3/42 (7.14%)  5 3/42 (7.14%)  3
Renal and urinary disorders     
Proteinuria  1  5/42 (11.90%)  7 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/42 (14.29%)  6 5/42 (11.90%)  5
Dyspnoea  1  6/42 (14.29%)  6 2/42 (4.76%)  2
Dyspnoea exertional  1  5/42 (11.90%)  5 1/42 (2.38%)  1
Epistaxis  1  3/42 (7.14%)  3 5/42 (11.90%)  5
Nasal congestion  1  2/42 (4.76%)  2 3/42 (7.14%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  5/42 (11.90%)  6 5/42 (11.90%)  6
Dry skin  1  3/42 (7.14%)  3 2/42 (4.76%)  2
Rash  1  8/42 (19.05%)  10 6/42 (14.29%)  7
Vascular disorders     
Flushing  1  0/42 (0.00%)  0 3/42 (7.14%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 7
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 1-800-545-5979
Responsible Party: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00192075     History of Changes
Other Study ID Numbers: 8142
B9E-US-S337 ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: October 30, 2008
Results First Posted: December 23, 2009
Last Update Posted: February 7, 2011