Trial Outcomes & Findings for A Study in Second Line Metastatic Colorectal Cancer (NCT NCT01183780)
NCT ID: NCT01183780
Last Updated: 2019-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1072 participants
Primary outcome timeframe
Randomization to Date of Death from Any Cause Up to 39.36 Months
Results posted on
2019-09-25
Participant Flow
Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.
Participant milestones
| Measure |
Ramucirumab + FOLFIRI
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.
|
Placebo + FOLFIRI
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 Study
STARTED
|
536
|
536
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
528
|
529
|
|
Overall Study
COMPLETED
|
505
|
511
|
|
Overall Study
NOT COMPLETED
|
31
|
25
|
Reasons for withdrawal
| Measure |
Ramucirumab + FOLFIRI
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.
|
Placebo + FOLFIRI
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 Study
Withdrawal by Subject
|
25
|
14
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
Baseline Characteristics
A Study in Second Line Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab + FOLFIRI
n=536 Participants
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.
|
Placebo + FOLFIRI
n=536 Participants
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
n=1072 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
111 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
324 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
212 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Age, Continuous
|
62.0 years
n=5 Participants
|
62.0 years
n=7 Participants
|
62.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
289 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
248 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
250 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
526 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
405 Participants
n=5 Participants
|
410 Participants
n=7 Participants
|
815 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
141 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
51 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
74 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Date of Death from Any Cause Up to 39.36 MonthsPopulation: All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
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.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=536 Participants
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.
|
Placebo + FOLFIRI
n=536 Participants
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 Survival (OS)
|
13.3 months
Interval 12.4 to 14.5
|
11.7 months
Interval 10.8 to 12.7
|
SECONDARY outcome
Timeframe: Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 MonthsPopulation: All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.
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.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=536 Participants
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.
|
Placebo + FOLFIRI
n=536 Participants
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.
|
|---|---|---|
|
Progression-free Survival (PFS) Time
|
5.7 months
Interval 5.5 to 6.2
|
4.5 months
Interval 4.2 to 5.4
|
SECONDARY outcome
Timeframe: Randomization until Disease Progression Up to 38.01 MonthsPopulation: All randomized participants.
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.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=536 Participants
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.
|
Placebo + FOLFIRI
n=536 Participants
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.
|
|---|---|---|
|
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
|
13.4 percentage of participants
Interval 10.7 to 16.6
|
12.5 percentage of participants
Interval 9.8 to 15.6
|
SECONDARY outcome
Timeframe: Baseline Up to 171 WeeksPopulation: All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=491 Participants
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.
|
Placebo + FOLFIRI
n=486 Participants
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.
|
|---|---|---|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
|
4.0 units on a scale
Standard Deviation 20.61
|
6.6 units on a scale
Standard Deviation 18.84
|
SECONDARY outcome
Timeframe: Baseline and 30-Day Follow-Up (FU) up to 171 WeeksPopulation: All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
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.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=308 Participants
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.
|
Placebo + FOLFIRI
n=310 Participants
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.
|
|---|---|---|
|
Change From Baseline in EuroQol- 5D (EQ-5D)
|
-0.097 units on a scale
Standard Deviation 0.279
|
-0.103 units on a scale
Standard Deviation 0.264
|
SECONDARY outcome
Timeframe: Cycles 1, 3, 5, and 30-Day FUPopulation: All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
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.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=516 Participants
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.
|
Placebo + FOLFIRI
n=512 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Immunogenicity Any Time During Study (n=516, 512)
|
5.6 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Immunogenicity Post-Treatment (n=477, 473)
|
3.1 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17Population: All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.
Outcome measures
| Measure |
Ramucirumab + FOLFIRI
n=248 Participants
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.
|
Placebo + FOLFIRI
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.
|
|---|---|---|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmin Dose 3 (n=248)
|
46.3 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 45.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmin Dose 5 (n=154)
|
65.1 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 43.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmin Dose 9 (n=27)
|
77.9 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 51.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmax Dose 13 (n=12)
|
307.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 33.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmax Dose 17 (n=7)
|
253.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 19.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmin Dose 13 (n=11)
|
75.9 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 43.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmin Dose 17 (n=5)
|
72.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 49.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmax Dose 3 (n=88)
|
221.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 37.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmax Dose 5 (n=51)
|
243.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 39.0
|
—
|
|
Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab
Cmax Dose 9 (n=18)
|
262.0 micrograms/milliliter (ug/mL)
Geometric Coefficient of Variation 36.0
|
—
|
Adverse Events
FOLFIRI + Ramucirumab
Serious events: 198 serious events
Other events: 518 other events
Deaths: 0 deaths
FOLFIRI + Placebo
Serious events: 175 serious events
Other events: 510 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFIRI + Ramucirumab
n=529 participants at risk
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.
|
FOLFIRI + Placebo
n=528 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
15/529 • Number of events 16
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.
|
1.5%
8/528 • Number of events 8
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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
6/529 • Number of events 7
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 4
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.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Cardiac disorders
Angina pectoris
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Cardiac disorders
Cardiac failure
|
0.38%
2/529 • Number of events 2
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/529
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Cardiac disorders
Right ventricular failure
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Eye disorders
Cataract
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
10/529 • Number of events 12
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.
|
2.7%
14/528 • Number of events 15
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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.38%
2/529 • Number of events 3
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Ascites
|
0.19%
1/529 • Number of events 2
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Gastrointestinal disorders
Colitis
|
0.38%
2/529 • Number of events 2
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.
|
0.38%
2/528 • Number of events 4
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.
|
|
Gastrointestinal disorders
Constipation
|
0.38%
2/529 • Number of events 3
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.
|
0.57%
3/528 • Number of events 4
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
19/529 • Number of events 20
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.
|
3.4%
18/528 • Number of events 21
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.57%
3/529 • Number of events 3
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 2
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.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Haematemesis
|
0.57%
3/529 • Number of events 3
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Ileus
|
0.57%
3/529 • Number of events 5
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.
|
1.1%
6/528 • Number of events 6
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.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
8/529 • Number of events 8
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.
|
2.1%
11/528 • Number of events 11
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.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.57%
3/529 • Number of events 3
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.57%
3/529 • Number of events 3
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.76%
4/529 • Number of events 4
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.76%
4/528 • Number of events 4
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.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
8/529 • Number of events 8
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.
|
1.1%
6/528 • Number of events 8
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.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Proctalgia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
7/529 • Number of events 7
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.
|
0.95%
5/528 • Number of events 5
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.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/529
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Gastrointestinal disorders
Subileus
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
13/529 • Number of events 14
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.
|
1.1%
6/528 • Number of events 7
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.
|
|
General disorders
Asthenia
|
0.76%
4/529 • Number of events 4
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
General disorders
Chest pain
|
0.19%
1/529 • Number of events 1
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
General disorders
Disease progression
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
General disorders
Fatigue
|
0.95%
5/529 • Number of events 5
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.
|
0.76%
4/528 • Number of events 4
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.
|
|
General disorders
General physical health deterioration
|
0.57%
3/529 • Number of events 4
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.
|
0.95%
5/528 • Number of events 5
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.
|
|
General disorders
Hernia obstructive
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
General disorders
Malaise
|
0.57%
3/529 • Number of events 3
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.
|
0.00%
0/528
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.
|
|
General disorders
Mucosal inflammation
|
0.76%
4/529 • Number of events 5
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
General disorders
Multi-organ failure
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
General disorders
Non-cardiac chest pain
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
General disorders
Oedema peripheral
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
General disorders
Pyrexia
|
0.76%
4/529 • Number of events 5
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.
|
1.5%
8/528 • Number of events 10
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.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
General disorders
Ulcer haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Cholangitis chronic
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 2
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.
|
|
Hepatobiliary disorders
Jaundice
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.19%
1/529 • Number of events 2
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Immune system disorders
Anaphylactic reaction
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Abdominal infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Bacteraemia
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Biliary tract infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
4/529 • Number of events 5
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Cystitis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 3
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.
|
|
Infections and infestations
Device related infection
|
0.19%
1/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Escherichia sepsis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Infection
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Influenza
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Infections and infestations
Localised infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Lung abscess
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Lung infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Mastoiditis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Pelvic abscess
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Pelvic infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Infections and infestations
Peritonitis
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Peritonitis bacterial
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Pneumonia
|
1.3%
7/529 • Number of events 7
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.
|
1.3%
7/528 • Number of events 7
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.
|
|
Infections and infestations
Pyelonephritis
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Salmonellosis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Sepsis
|
0.95%
5/529 • Number of events 5
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.
|
2.1%
11/528 • Number of events 13
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.
|
|
Infections and infestations
Septic shock
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Sinusitis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
4/529 • Number of events 4
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.
|
0.95%
5/528 • Number of events 6
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.
|
|
Infections and infestations
Wound infection
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.95%
5/529 • Number of events 5
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Investigations
Blood bilirubin increased
|
0.57%
3/529 • Number of events 3
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Investigations
Blood creatinine increased
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Investigations
Blood culture positive
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Investigations
Eastern cooperative oncology group performance status worsened
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 4
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.
|
|
Investigations
International normalised ratio increased
|
0.57%
3/529 • Number of events 3
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.
|
0.00%
0/528
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.
|
|
Investigations
Neutrophil count decreased
|
0.38%
2/529 • Number of events 3
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Investigations
Platelet count decreased
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Investigations
Weight decreased
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
7/529 • Number of events 8
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.
|
0.57%
3/528 • Number of events 4
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.57%
3/529 • Number of events 4
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.
|
1.1%
6/528 • Number of events 7
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
1/529 • Number of events 3
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.
|
0.57%
3/528 • Number of events 9
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.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.38%
2/529 • Number of events 3
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/529
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Aphasia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Dizziness
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Nervous system disorders
Dysarthria
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Epilepsy
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Headache
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Hyperammonaemic encephalopathy
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Optic neuritis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Syncope
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Psychiatric disorders
Anxiety
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Psychiatric disorders
Confusional state
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Psychiatric disorders
Depression
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Psychiatric disorders
Disorientation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Psychiatric disorders
Mental status changes
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Renal and urinary disorders
Haematuria
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 2
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.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.38%
2/529 • Number of events 2
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.57%
3/529 • Number of events 6
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.
|
0.00%
0/528
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.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.57%
3/529 • Number of events 4
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.
|
1.1%
6/528 • Number of events 6
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.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Renal and urinary disorders
Urinary retention
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.19%
1/529 • Number of events 1
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.
|
0.95%
5/528 • Number of events 6
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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.19%
1/529 • Number of events 3
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.19%
1/529 • Number of events 1
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.
|
0.57%
3/528 • Number of events 4
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/529 • Number of events 1
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
10/529 • Number of events 10
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.
|
1.1%
6/528 • Number of events 6
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.38%
2/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Surgical and medical procedures
Cancer surgery
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Surgical and medical procedures
Colostomy closure
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Surgical and medical procedures
Enterostomy
|
0.19%
1/529 • Number of events 2
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.
|
0.00%
0/528
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.
|
|
Surgical and medical procedures
High frequency ablation
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.38%
2/529 • Number of events 2
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Vascular disorders
Embolism
|
0.38%
2/529 • Number of events 2
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.
|
0.57%
3/528 • Number of events 3
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.
|
|
Vascular disorders
Hypertension
|
0.76%
4/529 • Number of events 4
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.
|
0.00%
0/528
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.
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
1/529 • Number of events 1
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.
|
0.00%
0/528
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.
|
|
Vascular disorders
Hypotension
|
0.38%
2/529 • Number of events 3
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.19%
1/529 • Number of events 1
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.
|
0.38%
2/528 • Number of events 2
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.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Vena cava embolism
|
0.00%
0/529
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.
|
0.19%
1/528 • Number of events 1
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.
|
|
Vascular disorders
Venous thrombosis
|
0.57%
3/529 • Number of events 3
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.
|
0.19%
1/528 • Number of events 1
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.
|
Other adverse events
| Measure |
FOLFIRI + Ramucirumab
n=529 participants at risk
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.
|
FOLFIRI + Placebo
n=528 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
93/529 • Number of events 225
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.
|
22.2%
117/528 • Number of events 270
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.6%
183/529 • Number of events 510
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.
|
24.8%
131/528 • Number of events 259
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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.1%
80/529 • Number of events 177
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.
|
8.0%
42/528 • Number of events 82
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
22/529 • Number of events 26
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.
|
5.1%
27/528 • Number of events 29
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.4%
124/529 • Number of events 178
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.
|
23.3%
123/528 • Number of events 181
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.
|
|
Gastrointestinal disorders
Constipation
|
29.7%
157/529 • Number of events 227
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.
|
25.0%
132/528 • Number of events 196
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
59.5%
315/529 • Number of events 881
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.
|
51.3%
271/528 • Number of events 798
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
26/529 • Number of events 28
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.
|
5.1%
27/528 • Number of events 32
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.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.1%
27/529 • Number of events 33
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.
|
1.1%
6/528 • Number of events 7
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.
|
|
Gastrointestinal disorders
Nausea
|
50.1%
265/529 • Number of events 650
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.
|
51.9%
274/528 • Number of events 715
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.
|
|
Gastrointestinal disorders
Proctalgia
|
5.1%
27/529 • Number of events 35
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.
|
2.5%
13/528 • Number of events 16
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.
|
|
Gastrointestinal disorders
Stomatitis
|
31.4%
166/529 • Number of events 380
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.
|
21.4%
113/528 • Number of events 235
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.
|
|
Gastrointestinal disorders
Vomiting
|
28.5%
151/529 • Number of events 299
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.
|
27.1%
143/528 • Number of events 309
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.
|
|
General disorders
Asthenia
|
14.0%
74/529 • Number of events 228
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.
|
11.7%
62/528 • Number of events 168
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.
|
|
General disorders
Fatigue
|
48.0%
254/529 • Number of events 645
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.
|
42.6%
225/528 • Number of events 588
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.
|
|
General disorders
Malaise
|
7.8%
41/529 • Number of events 97
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.
|
7.2%
38/528 • Number of events 104
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.
|
|
General disorders
Mucosal inflammation
|
17.2%
91/529 • Number of events 218
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.
|
9.8%
52/528 • Number of events 92
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.
|
|
General disorders
Oedema peripheral
|
22.3%
118/529 • Number of events 148
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.
|
9.5%
50/528 • Number of events 59
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.
|
|
General disorders
Pyrexia
|
16.1%
85/529 • Number of events 135
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.
|
11.6%
61/528 • Number of events 93
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
36/529 • Number of events 44
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.
|
4.2%
22/528 • Number of events 25
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.
|
|
Infections and infestations
Urinary tract infection
|
6.4%
34/529 • Number of events 43
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.
|
4.0%
21/528 • Number of events 35
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.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
28/529 • Number of events 59
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.
|
3.6%
19/528 • Number of events 59
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.
|
|
Investigations
Aspartate aminotransferase increased
|
6.4%
34/529 • Number of events 57
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.
|
3.4%
18/528 • Number of events 42
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.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
36/529 • Number of events 66
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.
|
5.1%
27/528 • Number of events 57
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.
|
|
Investigations
Neutrophil count decreased
|
25.9%
137/529 • Number of events 437
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.
|
21.8%
115/528 • Number of events 278
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.
|
|
Investigations
Platelet count decreased
|
15.1%
80/529 • Number of events 232
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.
|
6.8%
36/528 • Number of events 59
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.
|
|
Investigations
Weight decreased
|
14.4%
76/529 • Number of events 124
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.
|
8.7%
46/528 • Number of events 69
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.
|
|
Investigations
White blood cell count decreased
|
9.3%
49/529 • Number of events 146
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.
|
9.7%
51/528 • Number of events 136
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.4%
203/529 • Number of events 382
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.
|
28.2%
149/528 • Number of events 359
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.0%
32/529 • Number of events 46
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.
|
4.9%
26/528 • Number of events 32
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.6%
35/529 • Number of events 59
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.
|
2.5%
13/528 • Number of events 20
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
39/529 • Number of events 65
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.
|
7.2%
38/528 • Number of events 72
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
33/529 • Number of events 38
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.
|
4.2%
22/528 • Number of events 26
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
43/529 • Number of events 54
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.
|
9.1%
48/528 • Number of events 128
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
36/529 • Number of events 58
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.
|
3.6%
19/528 • Number of events 25
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.
|
|
Nervous system disorders
Dizziness
|
7.2%
38/529 • Number of events 46
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.
|
6.2%
33/528 • Number of events 51
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.
|
|
Nervous system disorders
Dysgeusia
|
8.1%
43/529 • Number of events 57
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.
|
7.4%
39/528 • Number of events 57
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.
|
|
Nervous system disorders
Headache
|
15.1%
80/529 • Number of events 114
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.
|
7.8%
41/528 • Number of events 69
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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
33/529 • Number of events 57
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.
|
7.2%
38/528 • Number of events 49
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.
|
|
Psychiatric disorders
Insomnia
|
8.9%
47/529 • Number of events 51
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.
|
10.2%
54/528 • Number of events 84
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.
|
|
Renal and urinary disorders
Proteinuria
|
17.8%
94/529 • Number of events 227
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.
|
5.7%
30/528 • Number of events 40
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
69/529 • Number of events 88
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.
|
8.7%
46/528 • Number of events 60
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
31/529 • Number of events 32
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.
|
0.95%
5/528 • Number of events 6
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
56/529 • Number of events 86
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.
|
9.7%
51/528 • Number of events 70
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
34.4%
182/529 • Number of events 254
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.
|
15.2%
80/528 • Number of events 99
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.7%
30/529 • Number of events 81
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.
|
3.2%
17/528 • Number of events 22
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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
29.5%
156/529 • Number of events 198
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.
|
31.8%
168/528 • Number of events 191
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.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.5%
29/529 • Number of events 35
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.
|
4.4%
23/528 • Number of events 25
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.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
13.0%
69/529 • Number of events 108
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.
|
5.5%
29/528 • Number of events 39
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
42/529 • Number of events 47
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.
|
6.8%
36/528 • Number of events 45
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.
|
|
Vascular disorders
Hypertension
|
27.8%
147/529 • Number of events 287
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.
|
9.7%
51/528 • Number of events 108
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.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER