Trial Outcomes & Findings for A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer (NCT NCT01246960)
NCT ID: NCT01246960
Last Updated: 2014-10-08
Results Overview
PFS was defined using Response Evaluation Criteria in Solid Tumors \[RECIST version (v.) 1.1\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
Randomization to measured PD or date of death from any cause (up to Month 25.0)
Results posted on
2014-10-08
Participant Flow
Participant milestones
| Measure |
Ramucirumab and mFOLFOX6
Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin 85 milligrams per square meter (mg/m\^2)
* Leucovorin 400 mg/m\^2
* 5-Fluorouracil (5-FU) 400 mg/m\^2 bolus
* 5-FU 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin 85 mg/m\^2
* Leucovorin 400 mg/m\^2
* 5-FU 400 mg/m\^2 bolus
* 5-FU 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
|
Overall Study
Received Any Quantity of Study Drug
|
82
|
80
|
|
Overall Study
COMPLETED
|
78
|
80
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Ramucirumab and mFOLFOX6
Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin 85 milligrams per square meter (mg/m\^2)
* Leucovorin 400 mg/m\^2
* 5-Fluorouracil (5-FU) 400 mg/m\^2 bolus
* 5-FU 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin 85 mg/m\^2
* Leucovorin 400 mg/m\^2
* 5-FU 400 mg/m\^2 bolus
* 5-FU 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal (by participant or physician)
|
3
|
3
|
Baseline Characteristics
A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab and mFOLFOX6
n=84 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=84 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
42 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
77 participants
n=5 Participants
|
76 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
84 participants
n=7 Participants
|
168 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to measured PD or date of death from any cause (up to Month 25.0)Population: ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.
PFS was defined using Response Evaluation Criteria in Solid Tumors \[RECIST version (v.) 1.1\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=84 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=84 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
6.4 months
Interval 5.8 to 9.3
|
6.7 months
Interval 5.6 to 7.8
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause (up to Month 28.3)Population: ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.
OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=84 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=84 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Overall Survival (OS)
|
11.7 months
Interval 10.2 to 14.6
|
11.5 months
Interval 9.0 to 15.3
|
SECONDARY outcome
Timeframe: Randomization to measured PD (up to Month 23.0)Population: ITT population: all randomized participants.
The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)\*100.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=84 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=84 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
|
45.2 percentage of participants
Interval 34.3 to 56.5
|
46.4 percentage of participants
Interval 35.5 to 57.6
|
SECONDARY outcome
Timeframe: Time of first response to measured PD (up to Month 23.0)Population: Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.
Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=38 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=39 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Duration of Response
|
7.4 months
Interval 4.2 to 8.4
|
5.8 months
Interval 4.4 to 8.0
|
SECONDARY outcome
Timeframe: Randomization to measured PD (up to Month 25.0)Population: ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.
TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=84 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=84 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Time to Disease Progression (TTP)
|
8.7 months
Interval 6.0 to 9.8
|
7.1 months
Interval 5.8 to 9.2
|
SECONDARY outcome
Timeframe: Months 1, 2, 4, 6, and 8Population: Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.
Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=81 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=77 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through study completion (up to Month 28.3)Population: Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).
Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Ramucirumab and mFOLFOX6
n=82 Participants
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=80 Participants
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE with Outcome of Death
|
5 participants
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
Any Ramucirumab/Placebo-Related AE
|
64 participants
|
64 participants
|
|
Number of Participants With Adverse Events (AEs)
Any Ramucirumab/Placebo-Related SAE
|
10 participants
|
12 participants
|
|
Number of Participants With Adverse Events (AEs)
Any Ramucirumab/Placebo-Related ≥Grade 3 AE
|
36 participants
|
33 participants
|
|
Number of Participants With Adverse Events (AEs)
Any Ramucirumab/Placebo-Related Grade 5 AE
|
0 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs)
Any AE Leading to Treatment Discontinuation
|
18 participants
|
5 participants
|
Adverse Events
Ramucirumab and mFOLFOX6
Serious events: 48 serious events
Other events: 82 other events
Deaths: 0 deaths
Placebo and mFOLFOX6
Serious events: 32 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab and mFOLFOX6
n=82 participants at risk
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=80 participants at risk
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.7%
3/82 • Number of events 3
|
0.00%
0/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
3/82 • Number of events 5
|
0.00%
0/80
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
3/82 • Number of events 3
|
2.5%
2/80 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
2/82 • Number of events 3
|
0.00%
0/80
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Arteriospasm coronary
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/82
|
2.5%
2/80 • Number of events 2
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Cardiac tamponade
|
1.2%
1/82 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/82 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
1/82 • Number of events 2
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
2.4%
2/82 • Number of events 2
|
0.00%
0/80
|
|
Gastrointestinal disorders
Gastric perforation
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.9%
4/82 • Number of events 4
|
3.8%
3/80 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.2%
1/82 • Number of events 2
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Nausea
|
6.1%
5/82 • Number of events 6
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
1.2%
1/82 • Number of events 2
|
0.00%
0/80
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Oesophagitis
|
2.4%
2/82 • Number of events 2
|
0.00%
0/80
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
3/82 • Number of events 4
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Asthenia
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
General disorders
Death
|
0.00%
0/82
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Device dislocation
|
0.00%
0/82
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Disease progression
|
1.2%
1/82 • Number of events 1
|
3.8%
3/80 • Number of events 3
|
|
General disorders
Multi-organ failure
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/82 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Pain
|
1.2%
1/82 • Number of events 1
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Pyrexia
|
2.4%
2/82 • Number of events 3
|
1.2%
1/80 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Hepatobiliary disorders
Hepatic failure
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/82
|
2.5%
2/80 • Number of events 2
|
|
Infections and infestations
Catheter site infection
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Cellulitis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Kidney infection
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Lung infection
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Infections and infestations
Peritonitis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Pneumonia
|
3.7%
3/82 • Number of events 3
|
0.00%
0/80
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Infections and infestations
Sepsis
|
3.7%
3/82 • Number of events 3
|
3.8%
3/80 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
3/82 • Number of events 3
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.2%
1/82 • Number of events 2
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.7%
3/82 • Number of events 3
|
1.2%
1/80 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
2.4%
2/82 • Number of events 2
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Hydronephrosis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Renal and urinary disorders
Renal injury
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.4%
2/82 • Number of events 3
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
2/82 • Number of events 2
|
2.5%
2/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/82 • Number of events 1
|
3.8%
3/80 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
2/82 • Number of events 3
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
2/82 • Number of events 2
|
0.00%
0/80
|
|
Vascular disorders
Deep vein thrombosis
|
6.1%
5/82 • Number of events 5
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Embolism venous
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Hypertension
|
1.2%
1/82 • Number of events 1
|
0.00%
0/80
|
|
Vascular disorders
Hypotension
|
1.2%
1/82 • Number of events 1
|
3.8%
3/80 • Number of events 3
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/82
|
1.2%
1/80 • Number of events 1
|
Other adverse events
| Measure |
Ramucirumab and mFOLFOX6
n=82 participants at risk
Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
Placebo and mFOLFOX6
n=80 participants at risk
Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.
mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).
* Oxaliplatin: 85 mg/m\^2
* Leucovorin: 400 mg/m\^2
* 5-FU: 400 mg/m\^2 bolus
* 5-FU: 2400 mg/m\^2 continuous given over 46-48 hours
Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.4%
29/82 • Number of events 41
|
47.5%
38/80 • Number of events 58
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.5%
7/82 • Number of events 18
|
11.2%
9/80 • Number of events 14
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.4%
29/82 • Number of events 76
|
41.2%
33/80 • Number of events 108
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.6%
30/82 • Number of events 62
|
25.0%
20/80 • Number of events 45
|
|
Eye disorders
Vision blurred
|
3.7%
3/82 • Number of events 3
|
7.5%
6/80 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
8/82 • Number of events 9
|
6.2%
5/80 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
20.7%
17/82 • Number of events 20
|
17.5%
14/80 • Number of events 20
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
8/82 • Number of events 10
|
10.0%
8/80 • Number of events 11
|
|
Gastrointestinal disorders
Ascites
|
6.1%
5/82 • Number of events 8
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
43.9%
36/82 • Number of events 41
|
40.0%
32/80 • Number of events 41
|
|
Gastrointestinal disorders
Diarrhoea
|
43.9%
36/82 • Number of events 67
|
41.2%
33/80 • Number of events 56
|
|
Gastrointestinal disorders
Dry mouth
|
7.3%
6/82 • Number of events 6
|
5.0%
4/80 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
7/82 • Number of events 9
|
10.0%
8/80 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
12.2%
10/82 • Number of events 15
|
16.2%
13/80 • Number of events 18
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
3/82 • Number of events 3
|
6.2%
5/80 • Number of events 5
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.3%
6/82 • Number of events 9
|
6.2%
5/80 • Number of events 11
|
|
Gastrointestinal disorders
Nausea
|
63.4%
52/82 • Number of events 72
|
70.0%
56/80 • Number of events 82
|
|
Gastrointestinal disorders
Oral pain
|
6.1%
5/82 • Number of events 6
|
5.0%
4/80 • Number of events 4
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
10/82 • Number of events 16
|
20.0%
16/80 • Number of events 21
|
|
Gastrointestinal disorders
Vomiting
|
39.0%
32/82 • Number of events 49
|
35.0%
28/80 • Number of events 42
|
|
General disorders
Asthenia
|
14.6%
12/82 • Number of events 13
|
10.0%
8/80 • Number of events 13
|
|
General disorders
Chest pain
|
2.4%
2/82 • Number of events 2
|
8.8%
7/80 • Number of events 11
|
|
General disorders
Chills
|
6.1%
5/82 • Number of events 5
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Fatigue
|
69.5%
57/82 • Number of events 91
|
70.0%
56/80 • Number of events 81
|
|
General disorders
Mucosal inflammation
|
20.7%
17/82 • Number of events 23
|
11.2%
9/80 • Number of events 13
|
|
General disorders
Oedema peripheral
|
24.4%
20/82 • Number of events 30
|
17.5%
14/80 • Number of events 19
|
|
General disorders
Pyrexia
|
11.0%
9/82 • Number of events 12
|
13.8%
11/80 • Number of events 11
|
|
General disorders
Temperature intolerance
|
9.8%
8/82 • Number of events 8
|
17.5%
14/80 • Number of events 17
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
6/82 • Number of events 6
|
6.2%
5/80 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
13.4%
11/82 • Number of events 11
|
11.2%
9/80 • Number of events 12
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
3/82 • Number of events 3
|
6.2%
5/80 • Number of events 5
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.5%
7/82 • Number of events 14
|
6.2%
5/80 • Number of events 7
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
5/82 • Number of events 6
|
8.8%
7/80 • Number of events 9
|
|
Investigations
Aspartate aminotransferase increased
|
8.5%
7/82 • Number of events 10
|
13.8%
11/80 • Number of events 18
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
6/82 • Number of events 7
|
18.8%
15/80 • Number of events 24
|
|
Investigations
Blood creatinine increased
|
6.1%
5/82 • Number of events 11
|
1.2%
1/80 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
19.5%
16/82 • Number of events 50
|
11.2%
9/80 • Number of events 16
|
|
Investigations
Platelet count decreased
|
23.2%
19/82 • Number of events 45
|
15.0%
12/80 • Number of events 24
|
|
Investigations
Weight decreased
|
34.1%
28/82 • Number of events 41
|
26.2%
21/80 • Number of events 31
|
|
Investigations
White blood cell count decreased
|
6.1%
5/82 • Number of events 8
|
7.5%
6/80 • Number of events 8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.1%
37/82 • Number of events 47
|
27.5%
22/80 • Number of events 36
|
|
Metabolism and nutrition disorders
Dehydration
|
25.6%
21/82 • Number of events 28
|
15.0%
12/80 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.0%
9/82 • Number of events 15
|
12.5%
10/80 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.1%
5/82 • Number of events 7
|
5.0%
4/80 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.0%
9/82 • Number of events 15
|
5.0%
4/80 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.5%
16/82 • Number of events 23
|
10.0%
8/80 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.7%
3/82 • Number of events 3
|
6.2%
5/80 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.7%
3/82 • Number of events 7
|
7.5%
6/80 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.3%
6/82 • Number of events 13
|
1.2%
1/80 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
2/82 • Number of events 4
|
10.0%
8/80 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
10/82 • Number of events 12
|
13.8%
11/80 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.5%
7/82 • Number of events 7
|
8.8%
7/80 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.8%
8/82 • Number of events 14
|
6.2%
5/80 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/82 • Number of events 1
|
7.5%
6/80 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.0%
9/82 • Number of events 9
|
8.8%
7/80 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.3%
6/82 • Number of events 6
|
2.5%
2/80 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
23.2%
19/82 • Number of events 22
|
15.0%
12/80 • Number of events 15
|
|
Nervous system disorders
Dysgeusia
|
15.9%
13/82 • Number of events 14
|
17.5%
14/80 • Number of events 15
|
|
Nervous system disorders
Headache
|
22.0%
18/82 • Number of events 24
|
15.0%
12/80 • Number of events 16
|
|
Nervous system disorders
Memory impairment
|
6.1%
5/82 • Number of events 5
|
0.00%
0/80
|
|
Nervous system disorders
Paraesthesia
|
9.8%
8/82 • Number of events 10
|
25.0%
20/80 • Number of events 33
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
3/82 • Number of events 3
|
7.5%
6/80 • Number of events 8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
53.7%
44/82 • Number of events 68
|
53.8%
43/80 • Number of events 73
|
|
Psychiatric disorders
Anxiety
|
4.9%
4/82 • Number of events 4
|
10.0%
8/80 • Number of events 8
|
|
Psychiatric disorders
Depression
|
8.5%
7/82 • Number of events 7
|
5.0%
4/80 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
18.3%
15/82 • Number of events 15
|
25.0%
20/80 • Number of events 24
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/82
|
6.2%
5/80 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.2%
19/82 • Number of events 21
|
18.8%
15/80 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
9.8%
8/82 • Number of events 8
|
1.2%
1/80 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.5%
16/82 • Number of events 23
|
20.0%
16/80 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
29.3%
24/82 • Number of events 28
|
11.2%
9/80 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
2/82 • Number of events 2
|
7.5%
6/80 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
5/82 • Number of events 5
|
2.5%
2/80 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.0%
9/82 • Number of events 10
|
10.0%
8/80 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
3/82 • Number of events 3
|
11.2%
9/80 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
3/82 • Number of events 6
|
7.5%
6/80 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
4/82 • Number of events 4
|
6.2%
5/80 • Number of events 6
|
|
Vascular disorders
Hypertension
|
36.6%
30/82 • Number of events 41
|
12.5%
10/80 • Number of events 10
|
|
Vascular disorders
Hypotension
|
8.5%
7/82 • Number of events 10
|
8.8%
7/80 • Number of events 14
|
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