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A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma (RAINBOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170663
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : July 31, 2014
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Biological: Ramucirumab (IMC-1211B) DP
Drug: Placebo
Drug: Paclitaxel
Enrollment 665
Recruitment Details  
Pre-assignment Details Completers include participants that discontinued study drugs either due to progressive disease (PD), due to an adverse event or died due to any cause, but not necessarily had any survival-FU assessment done.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description 8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Period Title: Overall Study
Started [1] 330 [2] 335 [3]
Received Any Treatment (Safety Pop) 327 329
Completed 316 315
Not Completed 14 20
Reason Not Completed
Lost to Follow-up             3             9
Withdrawal of consent without follow-up             11             11
[1]
One participant randomized to placebo/paclitaxel arm but received ramucirumab (IMC-1121B) in error.
[2]
Participant was included in ramucirumab (IMC-1121B)/paclitaxel treatment arm (safety population).
[3]
Participant was included in the placebo/paclitaxel treatment arm (intent-to-treat (ITT) population).
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel Total
Hide Arm/Group Description 8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 330 335 665
Hide Baseline Analysis Population Description
All randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 335 participants 665 participants
<=18 years 0 0 0
Between 18 and 65 years 205 213 418
>=65 years 125 122 247
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 330 participants 335 participants 665 participants
61
(25 to 83)
61
(24 to 84)
61
(24 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 335 participants 665 participants
Female 101 92 193
Male 229 243 472
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 335 participants 665 participants
Hispanic or Latino 31 26 57
Not Hispanic or Latino 299 309 608
Unknown or Not Reported 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 335 participants 665 participants
American Indian or Alaska Native 0 1 1
Asian 110 121 231
Black or African American 6 6 12
White 208 199 407
More than one race 0 1 1
Other 6 7 13
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 335 participants 665 participants
Portugal 2 0 2
United States 12 12 24
Estonia 5 5 10
Taiwan 14 16 30
Spain 8 13 21
Russia 8 13 21
Chile 1 3 4
Italy 13 15 28
France 20 14 34
Australia 18 23 41
South Korea 23 22 45
Lithuania 6 6 12
Austria 4 2 6
United Kingdom 6 9 15
Hungary 20 9 29
Mexico 2 2 4
Argentina 1 0 1
Poland 15 18 33
Brazil 19 16 35
Belgium 12 14 26
Singapore 2 3 5
Romania 7 7 14
Bulgaria 7 5 12
Germany 20 20 40
Japan 68 72 140
Hong Kong 2 1 3
Israel 15 15 30
1.Primary Outcome
Title Overall Survival Time (OS)
Hide Description OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
Time Frame Randomization up to 27.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 330 335
Median (95% Confidence Interval)
Unit of Measure: months
9.6
(8.5 to 10.8)
7.4
(6.3 to 8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab (IMC-1211B) Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0169
Comments [Not Specified]
Method Stratified Log Rank Test
Comments Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.807
Confidence Interval (2-Sided) 95%
0.678 to 0.962
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.
Time Frame Randomization up to 22.2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 330 335
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(4.2 to 5.3)
2.9
(2.8 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab (IMC-1211B) Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified Log Rank Test
Comments Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.635
Confidence Interval (2-Sided) 95%
0.536 to 0.752
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Progressive Disease (TTP)
Hide Description TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.
Time Frame Baseline up to 22.2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 330 335
Median (95% Confidence Interval)
Unit of Measure: months
5.52
(4.50 to 5.68)
3.02
(2.86 to 4.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab (IMC-1211B) Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified Log Rank Test
Comments Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.596
Confidence Interval (2-Sided) 95%
0.494 to 0.720
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
Hide Description BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 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 a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
Time Frame Randomization up to 22.2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 330 335
Measure Type: Number
Unit of Measure: percentage of participants
CR 0.6 0.3
PR 27.3 15.8
SD 52.1 47.5
PD 13.0 24.8
Not Evaluable 0.3 0.9
No Tumor Response Evaluation 6.7 10.7
5.Secondary Outcome
Title Percentage of Participants With CR or PR (Objective Response Rate [ORR])
Hide Description ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 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 a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.
Time Frame Randomization up to 22.2 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 330 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.9
(23.3 to 33.0)
16.1
(12.6 to 20.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab (IMC-1211B) Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.14
Confidence Interval (2-Sided) 95%
1.45 to 3.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
Hide Description Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
Time Frame Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 320 323
Measure Type: Number
Unit of Measure: percentage of participants
1.6 0.3
7.Secondary Outcome
Title Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion
Hide Description [Not Specified]
Time Frame Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 259
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (µg/mL)
146
(28%)
8.Secondary Outcome
Title Cmax After 4th Ramucirumab (IMC-1211B) Infusion
Hide Description [Not Specified]
Time Frame Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 200
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
193
(34%)
9.Secondary Outcome
Title Cmax After 7th Ramucirumab (IMC-1211B) Infusion
Hide Description [Not Specified]
Time Frame Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 127
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
216
(30%)
10.Secondary Outcome
Title Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion
Hide Description This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.
Time Frame Cycle 1, Day 1 predose (28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion
Hide Description [Not Specified]
Time Frame Cycle 2, Day 15 (28-day cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 203
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
45.0
(50%)
12.Secondary Outcome
Title Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion
Hide Description [Not Specified]
Time Frame Cycle 4, Day 1 (28-day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 142
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
62.8
(47%)
13.Secondary Outcome
Title Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
Hide Description EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. 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 symptoms scales, higher scores represented a greater degree of symptoms.
Time Frame Baseline, end of therapy (up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 209 202
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.5  (23.24) -12.1  (24.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab (IMC-1211B) Plus Paclitaxel, Placebo Plus Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3973
Comments Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
Hide Description The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
Time Frame Baseline, end of therapy (up to 103 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 205 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.16  (0.279) -0.19  (0.337)
15.Other Pre-specified Outcome
Title Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died
Hide Description Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame Baseline up to 103 weeks and within 30 days of last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.
Arm/Group Title Ramucirumab (IMC-1211B) Plus Paclitaxel Placebo Plus Paclitaxel
Hide Arm/Group Description:
8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
Overall Number of Participants Analyzed 327 329
Measure Type: Number
Unit of Measure: participants
SAEs 161 146
Other Non-serious AEs 324 321
Died 37 52
Time Frame [Not Specified]
Adverse Event Reporting Description One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).
 
Arm/Group Title Ramucirumab and Paclitaxel Placebo and Paclitaxel
Hide Arm/Group Description 8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle. Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
All-Cause Mortality
Ramucirumab and Paclitaxel Placebo and Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ramucirumab and Paclitaxel Placebo and Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/327 (49.24%)      146/329 (44.38%)    
Blood and lymphatic system disorders     
Anaemia  1  8/327 (2.45%)  8 7/329 (2.13%)  10
Disseminated intravascular coagulation  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Febrile neutropenia  1  8/327 (2.45%)  8 5/329 (1.52%)  6
Leukopenia  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Neutropenia  1  12/327 (3.67%)  17 4/329 (1.22%)  4
Cardiac disorders     
Acute coronary syndrome  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Angina pectoris  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Atrial fibrillation  1  3/327 (0.92%)  3 0/329 (0.00%)  0
Atrial flutter  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Atrial thrombosis  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Cardiac failure  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Extrasystoles  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Myocardial infarction  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Congenital, familial and genetic disorders     
Pyloric stenosis  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Ear and labyrinth disorders     
Hearing impaired  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Vertigo  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Eye disorders     
Cataract  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Lacrimation increased  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  10/327 (3.06%)  12 11/329 (3.34%)  12
Abdominal pain upper  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Anal haemorrhage  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Aphagia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Ascites  1  5/327 (1.53%)  8 3/329 (0.91%)  3
Constipation  1  0/327 (0.00%)  0 2/329 (0.61%)  2
Diarrhoea  1  5/327 (1.53%)  5 2/329 (0.61%)  2
Diverticular perforation  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Dysphagia  1  4/327 (1.22%)  4 3/329 (0.91%)  3
Gastric haemorrhage  1  3/327 (0.92%)  3 2/329 (0.61%)  2
Gastrointestinal haemorrhage  1  4/327 (1.22%)  4 2/329 (0.61%)  2
Gastrointestinal obstruction  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Gastrointestinal perforation  1  2/327 (0.61%)  3 0/329 (0.00%)  0
Haematemesis  1  3/327 (0.92%)  3 0/329 (0.00%)  0
Ileus  1  2/327 (0.61%)  3 0/329 (0.00%)  0
Ileus paralytic  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Intestinal ischaemia  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Intestinal obstruction  1  6/327 (1.83%)  6 3/329 (0.91%)  3
Intestinal perforation  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Malabsorption  1  1/327 (0.31%)  3 0/329 (0.00%)  0
Melaena  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Mouth ulceration  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Nausea  1  2/327 (0.61%)  3 5/329 (1.52%)  6
Obstruction gastric  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Odynophagia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Oesophageal food impaction  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Oesophageal haemorrhage  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Oesophageal perforation  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Oesophageal spasm  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Oesophageal stenosis  1  0/327 (0.00%)  0 2/329 (0.61%)  2
Oesophageal ulcer  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Oesophagitis  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Pancreatitis acute  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Peritonitis  1  5/327 (1.53%)  5 0/329 (0.00%)  0
Pneumatosis intestinalis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Small intestinal obstruction  1  3/327 (0.92%)  3 4/329 (1.22%)  5
Small intestinal stenosis  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Subileus  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Vomiting  1  7/327 (2.14%)  9 10/329 (3.04%)  11
General disorders     
Asthenia  1  5/327 (1.53%)  7 0/329 (0.00%)  0
Chest pain  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Death  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Device dislocation  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Disease progression  1  0/327 (0.00%)  0 2/329 (0.61%)  2
Drowning  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Fatigue  1  5/327 (1.53%)  5 7/329 (2.13%)  9
Feeling abnormal  1  0/327 (0.00%)  0 1/329 (0.30%)  1
General physical health deterioration  1  8/327 (2.45%)  10 9/329 (2.74%)  12
Injection site injury  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Multi-organ failure  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Oedema peripheral  1  3/327 (0.92%)  3 1/329 (0.30%)  1
Pain  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Pyrexia  1  8/327 (2.45%)  9 7/329 (2.13%)  9
Hepatobiliary disorders     
Bile duct obstruction  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Cholangitis  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Cholecystitis  1  3/327 (0.92%)  3 0/329 (0.00%)  0
Cholecystitis acute  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Jaundice  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Jaundice cholestatic  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Infections and infestations     
Anal abscess  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Appendicitis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Bacteraemia  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Biliary sepsis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Biliary tract infection  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Bronchopneumonia  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Cellulitis  1  0/327 (0.00%)  0 2/329 (0.61%)  3
Device related infection  1  2/327 (0.61%)  2 3/329 (0.91%)  3
Device related sepsis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Diarrhoea infectious  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Endocarditis  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Herpes zoster  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Infection  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Influenza  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Lobar pneumonia  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Localised infection  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Lower respiratory tract infection  1  0/327 (0.00%)  0 2/329 (0.61%)  3
Lung infection  1  3/327 (0.92%)  6 0/329 (0.00%)  0
Neutropenic sepsis  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Perirectal abscess  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Peritonitis bacterial  1  3/327 (0.92%)  3 0/329 (0.00%)  0
Pneumonia  1  3/327 (0.92%)  3 3/329 (0.91%)  3
Pseudomonas infection  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Pulmonary sepsis  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Respiratory tract infection  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Sepsis  1  5/327 (1.53%)  7 4/329 (1.22%)  5
Septic shock  1  3/327 (0.92%)  3 1/329 (0.30%)  2
Staphylococcal infection  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Staphylococcal sepsis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Urinary tract infection  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Urinary tract infection bacterial  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Urosepsis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Viral infection  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Wound infection  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Injury, poisoning and procedural complications     
Clavicle fracture  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Gastroenteritis radiation  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Incisional hernia  1  1/327 (0.31%)  3 0/329 (0.00%)  0
Spinal compression fracture  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Splenic rupture  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Anticoagulation drug level above therapeutic  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Aspartate aminotransferase increased  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Blood creatinine increased  1  1/327 (0.31%)  2 0/329 (0.00%)  0
Blood urea increased  1  1/327 (0.31%)  2 0/329 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Metabolism and nutrition disorders     
Cachexia  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Decreased appetite  1  2/327 (0.61%)  4 5/329 (1.52%)  6
Dehydration  1  6/327 (1.83%)  7 6/329 (1.82%)  7
Hypercalcaemia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Hypoalbuminaemia  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Hyponatraemia  1  3/327 (0.92%)  4 0/329 (0.00%)  0
Hypophagia  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Back pain  1  1/327 (0.31%)  1 2/329 (0.61%)  2
Flank pain  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Myalgia  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Pain in extremity  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Pathological fracture  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain cancer metastatic  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Cancer pain  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Malignant ascites  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Malignant neoplasm progression  1  48/327 (14.68%)  65 49/329 (14.89%)  66
Malignant pleural effusion  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Metastases to central nervous system  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Metastases to liver  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Metastases to meninges  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Metastases to spine  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Rectal cancer  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Tumour pain  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Nervous system disorders     
Akathisia  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Cerebral haemorrhage  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Cerebral infarction  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Cerebrovascular accident  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Coma  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Hydrocephalus  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Intracranial pressure increased  1  0/327 (0.00%)  0 1/329 (0.30%)  2
Ischaemic stroke  1  1/327 (0.31%)  2 0/329 (0.00%)  0
Spinal cord compression  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Renal and urinary disorders     
Azotaemia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Dysuria  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Hydronephrosis  1  2/327 (0.61%)  2 2/329 (0.61%)  2
Obstructive uropathy  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Renal failure  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Renal failure acute  1  1/327 (0.31%)  1 2/329 (0.61%)  3
Urinary retention  1  2/327 (0.61%)  2 1/329 (0.30%)  1
Reproductive system and breast disorders     
Gynaecomastia  1  1/226 (0.44%)  1 0/237 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Aspiration  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Dyspnoea  1  3/327 (0.92%)  3 4/329 (1.22%)  4
Haemoptysis  1  2/327 (0.61%)  2 0/329 (0.00%)  0
Hypoxia  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Interstitial lung disease  1  0/327 (0.00%)  0 3/329 (0.91%)  3
Lung infiltration  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Pleural effusion  1  5/327 (1.53%)  5 4/329 (1.22%)  5
Pneumonitis  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Pneumothorax  1  1/327 (0.31%)  1 1/329 (0.30%)  1
Pulmonary embolism  1  2/327 (0.61%)  3 6/329 (1.82%)  8
Respiratory failure  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Vascular disorders     
Arteriosclerosis  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Deep vein thrombosis  1  2/327 (0.61%)  2 2/329 (0.61%)  2
Hypotension  1  2/327 (0.61%)  3 0/329 (0.00%)  0
Hypovolaemic shock  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Vein disorder  1  1/327 (0.31%)  1 0/329 (0.00%)  0
Vena cava thrombosis  1  0/327 (0.00%)  0 1/329 (0.30%)  1
Venous thrombosis  1  0/327 (0.00%)  0 2/329 (0.61%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ramucirumab and Paclitaxel Placebo and Paclitaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   324/327 (99.08%)      321/329 (97.57%)    
Blood and lymphatic system disorders     
Anaemia  1  110/327 (33.64%)  261 116/329 (35.26%)  274
Leukopenia  1  111/327 (33.94%)  471 69/329 (20.97%)  199
Neutropenia  1  174/327 (53.21%)  878 102/329 (31.00%)  247
Thrombocytopenia  1  43/327 (13.15%)  103 20/329 (6.08%)  37
Gastrointestinal disorders     
Abdominal distension  1  20/327 (6.12%)  27 20/329 (6.08%)  25
Abdominal pain  1  98/327 (29.97%)  165 62/329 (18.84%)  104
Abdominal pain upper  1  31/327 (9.48%)  48 35/329 (10.64%)  52
Ascites  1  31/327 (9.48%)  46 25/329 (7.60%)  39
Constipation  1  70/327 (21.41%)  95 71/329 (21.58%)  89
Diarrhoea  1  105/327 (32.11%)  250 76/329 (23.10%)  126
Dysphagia  1  17/327 (5.20%)  25 17/329 (5.17%)  18
Nausea  1  114/327 (34.86%)  236 106/329 (32.22%)  183
Stomatitis  1  64/327 (19.57%)  103 24/329 (7.29%)  33
Vomiting  1  85/327 (25.99%)  142 65/329 (19.76%)  111
General disorders     
Asthenia  1  68/327 (20.80%)  179 45/329 (13.68%)  73
Fatigue  1  128/327 (39.14%)  281 104/329 (31.61%)  209
Oedema peripheral  1  82/327 (25.08%)  122 45/329 (13.68%)  57
Pyrexia  1  56/327 (17.13%)  83 35/329 (10.64%)  53
Infections and infestations     
Nasopharyngitis  1  23/327 (7.03%)  34 19/329 (5.78%)  24
Urinary tract infection  1  18/327 (5.50%)  22 11/329 (3.34%)  11
Investigations     
Alanine aminotransferase increased  1  20/327 (6.12%)  43 18/329 (5.47%)  22
Aspartate aminotransferase increased  1  27/327 (8.26%)  62 17/329 (5.17%)  23
Weight decreased  1  45/327 (13.76%)  79 49/329 (14.89%)  68
Metabolism and nutrition disorders     
Decreased appetite  1  131/327 (40.06%)  225 105/329 (31.91%)  172
Hypoalbuminaemia  1  31/327 (9.48%)  47 13/329 (3.95%)  16
Hyponatraemia  1  17/327 (5.20%)  23 9/329 (2.74%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia  1  29/327 (8.87%)  54 20/329 (6.08%)  25
Back pain  1  38/327 (11.62%)  48 39/329 (11.85%)  47
Myalgia  1  34/327 (10.40%)  62 32/329 (9.73%)  44
Pain in extremity  1  19/327 (5.81%)  21 10/329 (3.04%)  10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  17/327 (5.20%)  17 26/329 (7.90%)  26
Nervous system disorders     
Dizziness  1  20/327 (6.12%)  25 13/329 (3.95%)  16
Dysgeusia  1  29/327 (8.87%)  32 21/329 (6.38%)  23
Headache  1  32/327 (9.79%)  50 22/329 (6.69%)  37
Neuropathy peripheral  1  47/327 (14.37%)  88 30/329 (9.12%)  51
Paraesthesia  1  24/327 (7.34%)  41 25/329 (7.60%)  41
Peripheral sensory neuropathy  1  57/327 (17.43%)  122 36/329 (10.94%)  63
Polyneuropathy  1  18/327 (5.50%)  31 22/329 (6.69%)  38
Psychiatric disorders     
Insomnia  1  31/327 (9.48%)  32 26/329 (7.90%)  27
Renal and urinary disorders     
Proteinuria  1  55/327 (16.82%)  156 20/329 (6.08%)  34
Respiratory, thoracic and mediastinal disorders     
Cough  1  41/327 (12.54%)  46 26/329 (7.90%)  35
Dysphonia  1  17/327 (5.20%)  22 9/329 (2.74%)  13
Dyspnoea  1  41/327 (12.54%)  61 31/329 (9.42%)  38
Epistaxis  1  100/327 (30.58%)  157 23/329 (6.99%)  34
Skin and subcutaneous tissue disorders     
Alopecia  1  107/327 (32.72%)  137 127/329 (38.60%)  159
Dry skin  1  25/327 (7.65%)  28 10/329 (3.04%)  10
Pruritus  1  20/327 (6.12%)  23 11/329 (3.34%)  13
Rash  1  35/327 (10.70%)  44 25/329 (7.60%)  28
Vascular disorders     
Hypertension  1  78/327 (23.85%)  155 16/329 (4.86%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab in error. For ITT population this participant was included in placebo/paclitaxel group and for the Safety population included in the ramucirumab group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01170663    
Other Study ID Numbers: 13894
I4T-IE-JVBE ( Other Identifier: Eli Lilly and Company )
CP12-0922 ( Other Identifier: ImClone Systems )
2010-020426-18 ( EudraCT Number )
First Submitted: July 21, 2010
First Posted: July 27, 2010
Results First Submitted: July 1, 2014
Results First Posted: July 31, 2014
Last Update Posted: September 18, 2019