Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 125 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

A Study in Second Line Metastatic Colorectal Cancer

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: NCT01183780
Recruitment Status : Completed
First Posted : August 18, 2010
Results First Posted : July 15, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: Ramucirumab
Biological: Placebo
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil
Enrollment 1072
Recruitment Details  
Pre-assignment Details Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Period Title: Overall Study
Started 536 536
Received at Least 1 Dose of Study Drug 528 529
Completed 505 511
Not Completed 31 25
Reason Not Completed
Withdrawal by Subject             25             14
Lost to Follow-up             6             11
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI Total
Hide Arm/Group Description

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Total of all reporting groups
Overall Number of Baseline Participants 536 536 1072
Hide Baseline Analysis Population Description
All randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 536 participants 536 participants 1072 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
324
  60.4%
321
  59.9%
645
  60.2%
>=65 years
212
  39.6%
215
  40.1%
427
  39.8%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 536 participants 536 participants 1072 participants
62.0
(21.0 to 83.0)
62.0
(33.0 to 87.0)
62.0
(21.0 to 87.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 536 participants 536 participants 1072 participants
Female
247
  46.1%
210
  39.2%
457
  42.6%
Male
289
  53.9%
326
  60.8%
615
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 536 participants 536 participants 1072 participants
Hispanic or Latino
38
   7.1%
39
   7.3%
77
   7.2%
Not Hispanic or Latino
248
  46.3%
221
  41.2%
469
  43.8%
Unknown or Not Reported
250
  46.6%
276
  51.5%
526
  49.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 536 participants 536 participants 1072 participants
American Indian or Alaska Native
0
   0.0%
1
   0.2%
1
   0.1%
Asian
111
  20.7%
103
  19.2%
214
  20.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
2
   0.2%
Black or African American
14
   2.6%
16
   3.0%
30
   2.8%
White
405
  75.6%
410
  76.5%
815
  76.0%
More than one race
3
   0.6%
0
   0.0%
3
   0.3%
Unknown or Not Reported
2
   0.4%
5
   0.9%
7
   0.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 536 participants 536 participants 1072 participants
United States 141 142 283
Portugal 2 2 4
Taiwan 5 6 11
Greece 8 8 16
Spain 51 60 111
Israel 7 7 14
Italy 17 20 37
India 1 2 3
France 12 15 27
Puerto Rico 2 1 3
Australia 16 19 35
Denmark 3 8 11
Netherlands 9 5 14
Korea, Republic of 22 25 47
Finland 9 3 12
Austria 6 12 18
Czech Republic 40 37 77
Hungary 24 23 47
Argentina 7 11 18
Belgium 30 22 52
Brazil 2 3 5
Romania 19 14 33
Germany 19 25 44
Japan 74 62 136
Sweden 10 4 14
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
Time Frame Randomization to Date of Death from Any Cause Up to 39.36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 536 536
Median (95% Confidence Interval)
Unit of Measure: months
13.3
(12.4 to 14.5)
11.7
(10.8 to 12.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0219
Comments [Not Specified]
Method Log Rank
Comments The analysis was performed on stratified data.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.844
Confidence Interval (2-Sided) 95%
0.730 to 0.976
Estimation Comments The estimation was performed on stratified data.
2.Secondary Outcome
Title Progression-free Survival (PFS) Time
Hide Description PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
Time Frame Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 536 536
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(5.5 to 6.2)
4.5
(4.2 to 5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Log Rank
Comments Analysis was performed on stratified data.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.793
Confidence Interval (2-Sided) 95%
0.697 to 0.903
Estimation Comments Analysis was performed on stratified data.
3.Secondary Outcome
Title Percentage of Participants Achieving an Objective Response (Objective Response Rate)
Hide Description The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.
Time Frame Randomization until Disease Progression Up to 38.01 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 536 536
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.4
(10.7 to 16.6)
12.5
(9.8 to 15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + FOLFIRI, Placebo + FOLFIRI
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6336
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
Time Frame Baseline Up to 171 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 491 486
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (20.61) 6.6  (18.84)
5.Secondary Outcome
Title Change From Baseline in EuroQol- 5D (EQ-5D)
Hide Description The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
Time Frame Baseline and 30-Day Follow-Up (FU) up to 171 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 308 310
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.097  (0.279) -0.103  (0.264)
6.Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Hide Description Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.
Time Frame Cycles 1, 3, 5, and 30-Day FU
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
Arm/Group Title Ramucirumab + FOLFIRI Placebo + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 516 512
Measure Type: Number
Unit of Measure: percentage of participants
Immunogenicity Any Time During Study (n=516, 512) 5.6 5.5
Immunogenicity Post-Treatment (n=477, 473) 3.1 3.8
7.Secondary Outcome
Title Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Hide Description [Not Specified]
Time Frame Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.
Arm/Group Title Ramucirumab + FOLFIRI
Hide Arm/Group Description:

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

Overall Number of Participants Analyzed 248
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (ug/mL)
Cmin Dose 3 (n=248)
46.3
(45.0%)
Cmin Dose 5 (n=154)
65.1
(43.0%)
Cmin Dose 9 (n=27)
77.9
(51.0%)
Cmin Dose 13 (n=11)
75.9
(43.0%)
Cmin Dose 17 (n=5)
72.0
(49.0%)
Cmax Dose 3 (n=88)
221.0
(37.0%)
Cmax Dose 5 (n=51)
243.0
(39.0%)
Cmax Dose 9 (n=18)
262.0
(36.0%)
Cmax Dose 13 (n=12)
307.0
(33.0%)
Cmax Dose 17 (n=7)
253.0
(19.0%)
Time Frame [Not Specified]
Adverse Event Reporting Description One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.
 
Arm/Group Title FOLFIRI + Ramucirumab FOLFIRI + Placebo
Hide Arm/Group Description

On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Ramucirumab: 8 mg/kg administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.

Placebo: Administered intravenously.

Irinotecan: 180 mg/m^2 administered intravenously.

Folinic Acid: 400 mg/m^2 administered intravenously.

5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion.

All-Cause Mortality
FOLFIRI + Ramucirumab FOLFIRI + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FOLFIRI + Ramucirumab FOLFIRI + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   198/529 (37.43%)      175/528 (33.14%)    
Blood and lymphatic system disorders     
Anaemia  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Febrile neutropenia  1  15/529 (2.84%)  16 8/528 (1.52%)  8
Leukopenia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Neutropenia  1  6/529 (1.13%)  7 1/528 (0.19%)  1
Thrombocytopenia  1  0/529 (0.00%)  0 2/528 (0.38%)  4
Thrombotic microangiopathy  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Angina pectoris  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Atrial fibrillation  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Atrial flutter  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Cardiac failure  1  2/529 (0.38%)  2 2/528 (0.38%)  2
Cardio-respiratory arrest  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Congestive cardiomyopathy  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Myocardial infarction  1  0/529 (0.00%)  0 3/528 (0.57%)  3
Pericarditis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Right ventricular failure  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Congenital, familial and genetic disorders     
Pyloric stenosis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Eye disorders     
Cataract  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  10/529 (1.89%)  12 14/528 (2.65%)  15
Abdominal pain lower  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Abdominal pain upper  1  2/529 (0.38%)  3 0/528 (0.00%)  0
Anal fistula  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Anal haemorrhage  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Anal ulcer  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Ascites  1  1/529 (0.19%)  2 3/528 (0.57%)  3
Colitis  1  2/529 (0.38%)  2 2/528 (0.38%)  4
Constipation  1  2/529 (0.38%)  3 3/528 (0.57%)  4
Diarrhoea  1  19/529 (3.59%)  20 18/528 (3.41%)  21
Dyspepsia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Enteritis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Enterocolitis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Gastric haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Gastritis  1  3/529 (0.57%)  3 1/528 (0.19%)  1
Gastrointestinal inflammation  1  0/529 (0.00%)  0 1/528 (0.19%)  2
Gastrointestinal perforation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Haematemesis  1  3/529 (0.57%)  3 0/528 (0.00%)  0
Haemorrhoidal haemorrhage  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Hernial eventration  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Ileus  1  3/529 (0.57%)  5 6/528 (1.14%)  6
Incarcerated inguinal hernia  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Inflammatory bowel disease  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Inguinal hernia  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Intestinal haemorrhage  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Intestinal obstruction  1  8/529 (1.51%)  8 11/528 (2.08%)  11
Intestinal perforation  1  3/529 (0.57%)  3 0/528 (0.00%)  0
Large intestinal haemorrhage  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Large intestinal obstruction  1  3/529 (0.57%)  3 3/528 (0.57%)  3
Large intestinal stenosis  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Large intestine perforation  1  4/529 (0.76%)  4 1/528 (0.19%)  1
Lower gastrointestinal haemorrhage  1  1/529 (0.19%)  1 4/528 (0.76%)  4
Mechanical ileus  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Nausea  1  8/529 (1.51%)  8 6/528 (1.14%)  8
Oesophageal varices haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Oesophagitis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Proctalgia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Rectal haemorrhage  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Rectal obstruction  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Rectal perforation  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Rectal ulcer  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Small intestinal haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Small intestinal obstruction  1  7/529 (1.32%)  7 5/528 (0.95%)  5
Small intestinal perforation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Stomatitis  1  0/529 (0.00%)  0 3/528 (0.57%)  3
Subileus  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Vomiting  1  13/529 (2.46%)  14 6/528 (1.14%)  7
General disorders     
Asthenia  1  4/529 (0.76%)  4 3/528 (0.57%)  3
Chest pain  1  1/529 (0.19%)  1 3/528 (0.57%)  3
Disease progression  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Fatigue  1  5/529 (0.95%)  5 4/528 (0.76%)  4
General physical health deterioration  1  3/529 (0.57%)  4 5/528 (0.95%)  5
Hernia obstructive  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Malaise  1  3/529 (0.57%)  3 0/528 (0.00%)  0
Mucosal inflammation  1  4/529 (0.76%)  5 2/528 (0.38%)  2
Multi-organ failure  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Non-cardiac chest pain  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Oedema peripheral  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Pyrexia  1  4/529 (0.76%)  5 8/528 (1.52%)  10
Systemic inflammatory response syndrome  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Ulcer haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hepatobiliary disorders     
Acute hepatic failure  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Bile duct obstruction  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Bile duct stenosis  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Cholangitis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Cholangitis chronic  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Cholecystitis  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Cholelithiasis obstructive  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Cholestasis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Hepatic cirrhosis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hepatic failure  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hepatic function abnormal  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hepatorenal syndrome  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Hepatotoxicity  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Hyperbilirubinaemia  1  1/529 (0.19%)  1 1/528 (0.19%)  2
Jaundice  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Jaundice cholestatic  1  1/529 (0.19%)  2 2/528 (0.38%)  2
Liver disorder  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Portal hypertension  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Immune system disorders     
Anaphylactic reaction  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Drug hypersensitivity  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Infections and infestations     
Abdominal infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Atypical pneumonia  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Bacteraemia  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Biliary tract infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Bronchitis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Bronchopulmonary aspergillosis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Campylobacter gastroenteritis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Cellulitis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Clostridium difficile colitis  1  4/529 (0.76%)  5 1/528 (0.19%)  1
Cystitis  1  0/529 (0.00%)  0 1/528 (0.19%)  3
Device related infection  1  1/529 (0.19%)  2 1/528 (0.19%)  1
Device related sepsis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Erysipelas  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Escherichia sepsis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Gastroenteritis  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Herpes zoster  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Infection  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Infective exacerbation of chronic obstructive airways disease  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Influenza  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Klebsiella infection  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Klebsiella sepsis  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Localised infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Lung abscess  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Lung infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Mastoiditis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Neutropenic infection  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Oral candidiasis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Pelvic abscess  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Pelvic infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Perirectal abscess  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Peritonitis  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Peritonitis bacterial  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Pneumonia  1  7/529 (1.32%)  7 7/528 (1.33%)  7
Pyelonephritis  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Respiratory tract infection  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Salmonellosis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Sepsis  1  5/529 (0.95%)  5 11/528 (2.08%)  13
Septic shock  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Sinusitis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Upper respiratory tract infection  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Urinary tract infection  1  4/529 (0.76%)  4 5/528 (0.95%)  6
Wound infection  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Ankle fracture  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Compression fracture  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Fall  1  5/529 (0.95%)  5 2/528 (0.38%)  2
Femur fracture  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Fibula fracture  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hepatic haematoma  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Hip fracture  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Lower limb fracture  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Lumbar vertebral fracture  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Post procedural urine leak  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Procedural intestinal perforation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Spinal fracture  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Stoma site haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Subdural haematoma  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Wound dehiscence  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Aspartate aminotransferase increased  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Blood bilirubin increased  1  3/529 (0.57%)  3 2/528 (0.38%)  2
Blood creatinine increased  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Blood culture positive  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Eastern cooperative oncology group performance status worsened  1  0/529 (0.00%)  0 1/528 (0.19%)  4
International normalised ratio increased  1  3/529 (0.57%)  3 0/528 (0.00%)  0
Neutrophil count decreased  1  2/529 (0.38%)  3 1/528 (0.19%)  1
Platelet count decreased  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Weight decreased  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Decreased appetite  1  7/529 (1.32%)  8 3/528 (0.57%)  4
Dehydration  1  3/529 (0.57%)  4 6/528 (1.14%)  7
Hyperglycaemia  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Hypoalbuminaemia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hypokalaemia  1  1/529 (0.19%)  3 3/528 (0.57%)  9
Malnutrition  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Tumour lysis syndrome  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  2/529 (0.38%)  3 1/528 (0.19%)  1
Musculoskeletal pain  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Neuropathic arthropathy  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Rheumatoid arthritis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colorectal cancer metastatic  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Malignant ascites  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Malignant pleural effusion  1  0/529 (0.00%)  0 2/528 (0.38%)  2
Metastases to meninges  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Metastatic neoplasm  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Tumour haemorrhage  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Tumour pain  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Cerebral haematoma  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Cerebral ischaemia  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Cerebrovascular accident  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Dizziness  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Dysarthria  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Epilepsy  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Headache  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hyperammonaemic encephalopathy  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Ischaemic stroke  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Memory impairment  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Optic neuritis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Posterior reversible encephalopathy syndrome  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Presyncope  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Syncope  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Transient ischaemic attack  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Psychiatric disorders     
Alcohol abuse  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Anxiety  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Confusional state  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Delirium  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Depression  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Disorientation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Mental status changes  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Suicide attempt  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Renal and urinary disorders     
Acute prerenal failure  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Haematuria  1  1/529 (0.19%)  1 1/528 (0.19%)  2
Hydronephrosis  1  2/529 (0.38%)  2 1/528 (0.19%)  1
Nephrolithiasis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Nephrotic syndrome  1  3/529 (0.57%)  6 0/528 (0.00%)  0
Prerenal failure  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Renal failure  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Renal failure acute  1  3/529 (0.57%)  4 6/528 (1.14%)  6
Urinary incontinence  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Urinary retention  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Urinary tract obstruction  1  1/529 (0.19%)  2 0/528 (0.00%)  0
Reproductive system and breast disorders     
Pelvic pain  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Dyspnoea  1  1/529 (0.19%)  1 5/528 (0.95%)  6
Haemoptysis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Interstitial lung disease  1  1/529 (0.19%)  3 2/528 (0.38%)  2
Laryngeal inflammation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Lung infiltration  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Pleural effusion  1  1/529 (0.19%)  1 3/528 (0.57%)  4
Pneumothorax  1  1/529 (0.19%)  1 1/528 (0.19%)  1
Pneumothorax spontaneous  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Pulmonary embolism  1  10/529 (1.89%)  10 6/528 (1.14%)  6
Pulmonary oedema  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Respiratory arrest  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Respiratory distress  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermal cyst  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Skin ulcer  1  2/529 (0.38%)  2 0/528 (0.00%)  0
Surgical and medical procedures     
Cancer surgery  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Colostomy closure  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Enterostomy  1  1/529 (0.19%)  2 0/528 (0.00%)  0
High frequency ablation  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Vascular disorders     
Aortic dissection  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Deep vein thrombosis  1  2/529 (0.38%)  2 3/528 (0.57%)  3
Embolism  1  2/529 (0.38%)  2 3/528 (0.57%)  3
Hypertension  1  4/529 (0.76%)  4 0/528 (0.00%)  0
Hypertensive crisis  1  1/529 (0.19%)  1 0/528 (0.00%)  0
Hypotension  1  2/529 (0.38%)  3 1/528 (0.19%)  1
Hypovolaemic shock  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Jugular vein thrombosis  1  1/529 (0.19%)  1 2/528 (0.38%)  2
Lymphoedema  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Subclavian vein thrombosis  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Thrombophlebitis superficial  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Vena cava embolism  1  0/529 (0.00%)  0 1/528 (0.19%)  1
Venous thrombosis  1  3/529 (0.57%)  3 1/528 (0.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFIRI + Ramucirumab FOLFIRI + Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   518/529 (97.92%)      510/528 (96.59%)    
Blood and lymphatic system disorders     
Anaemia  1  93/529 (17.58%)  225 117/528 (22.16%)  270
Neutropenia  1  183/529 (34.59%)  510 131/528 (24.81%)  259
Thrombocytopenia  1  80/529 (15.12%)  177 42/528 (7.95%)  82
Gastrointestinal disorders     
Abdominal distension  1  22/529 (4.16%)  26 27/528 (5.11%)  29
Abdominal pain  1  124/529 (23.44%)  178 123/528 (23.30%)  181
Constipation  1  157/529 (29.68%)  227 132/528 (25.00%)  196
Diarrhoea  1  315/529 (59.55%)  881 271/528 (51.33%)  798
Dyspepsia  1  26/529 (4.91%)  28 27/528 (5.11%)  32
Haemorrhoids  1  27/529 (5.10%)  33 6/528 (1.14%)  7
Nausea  1  265/529 (50.09%)  650 274/528 (51.89%)  715
Proctalgia  1  27/529 (5.10%)  35 13/528 (2.46%)  16
Stomatitis  1  166/529 (31.38%)  380 113/528 (21.40%)  235
Vomiting  1  151/529 (28.54%)  299 143/528 (27.08%)  309
General disorders     
Asthenia  1  74/529 (13.99%)  228 62/528 (11.74%)  168
Fatigue  1  254/529 (48.02%)  645 225/528 (42.61%)  588
Malaise  1  41/529 (7.75%)  97 38/528 (7.20%)  104
Mucosal inflammation  1  91/529 (17.20%)  218 52/528 (9.85%)  92
Oedema peripheral  1  118/529 (22.31%)  148 50/528 (9.47%)  59
Pyrexia  1  85/529 (16.07%)  135 61/528 (11.55%)  93
Infections and infestations     
Upper respiratory tract infection  1  36/529 (6.81%)  44 22/528 (4.17%)  25
Urinary tract infection  1  34/529 (6.43%)  43 21/528 (3.98%)  35
Investigations     
Alanine aminotransferase increased  1  28/529 (5.29%)  59 19/528 (3.60%)  59
Aspartate aminotransferase increased  1  34/529 (6.43%)  57 18/528 (3.41%)  42
Blood alkaline phosphatase increased  1  36/529 (6.81%)  66 27/528 (5.11%)  57
Neutrophil count decreased  1  137/529 (25.90%)  437 115/528 (21.78%)  278
Platelet count decreased  1  80/529 (15.12%)  232 36/528 (6.82%)  59
Weight decreased  1  76/529 (14.37%)  124 46/528 (8.71%)  69
White blood cell count decreased  1  49/529 (9.26%)  146 51/528 (9.66%)  136
Metabolism and nutrition disorders     
Decreased appetite  1  203/529 (38.37%)  382 149/528 (28.22%)  359
Dehydration  1  32/529 (6.05%)  46 26/528 (4.92%)  32
Hypoalbuminaemia  1  35/529 (6.62%)  59 13/528 (2.46%)  20
Hypokalaemia  1  39/529 (7.37%)  65 38/528 (7.20%)  72
Musculoskeletal and connective tissue disorders     
Arthralgia  1  33/529 (6.24%)  38 22/528 (4.17%)  26
Back pain  1  43/529 (8.13%)  54 48/528 (9.09%)  128
Pain in extremity  1  36/529 (6.81%)  58 19/528 (3.60%)  25
Nervous system disorders     
Dizziness  1  38/529 (7.18%)  46 33/528 (6.25%)  51
Dysgeusia  1  43/529 (8.13%)  57 39/528 (7.39%)  57
Headache  1  80/529 (15.12%)  114 41/528 (7.77%)  69
Peripheral sensory neuropathy  1  33/529 (6.24%)  57 38/528 (7.20%)  49
Psychiatric disorders     
Insomnia  1  47/529 (8.88%)  51 54/528 (10.23%)  84
Renal and urinary disorders     
Proteinuria  1  94/529 (17.77%)  227 30/528 (5.68%)  40
Respiratory, thoracic and mediastinal disorders     
Cough  1  69/529 (13.04%)  88 46/528 (8.71%)  60
Dysphonia  1  31/529 (5.86%)  32 5/528 (0.95%)  6
Dyspnoea  1  56/529 (10.59%)  86 51/528 (9.66%)  70
Epistaxis  1  182/529 (34.40%)  254 80/528 (15.15%)  99
Hiccups  1  30/529 (5.67%)  81 17/528 (3.22%)  22
Skin and subcutaneous tissue disorders     
Alopecia  1  156/529 (29.49%)  198 168/528 (31.82%)  191
Dry skin  1  29/529 (5.48%)  35 23/528 (4.36%)  25
Palmar-plantar erythrodysaesthesia syndrome  1  69/529 (13.04%)  108 29/528 (5.49%)  39
Rash  1  42/529 (7.94%)  47 36/528 (6.82%)  45
Vascular disorders     
Hypertension  1  147/529 (27.79%)  287 51/528 (9.66%)  108
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01183780     History of Changes
Other Study ID Numbers: 13856
I4T-MC-JVBB ( Other Identifier: Eli Lilly and Company )
CP12-0920 ( Other Identifier: ImClone LLC Trial Number )
2010-021037-32 ( EudraCT Number )
CTRI/2011/07/001900 ( Registry Identifier: Clinical Trials Registry India )
First Submitted: August 4, 2010
First Posted: August 18, 2010
Results First Submitted: June 19, 2015
Results First Posted: July 15, 2015
Last Update Posted: September 25, 2019