Trial Outcomes & Findings for A Study of Ramucirumab or Icrucumab in Colorectal Cancer (NCT NCT01111604)
NCT ID: NCT01111604
Last Updated: 2019-08-06
Results Overview
PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)
Results posted on
2019-08-06
Participant Flow
Completers were defined as participants who had failure event (progressive disease, death), or were off treatment and censored due to study completion.
Participant milestones
| Measure |
mFOLFOX-6
mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W)
Folinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid \[LFA\]: 200 mg/m² Q2 weeks if FA is unavailable).
Fluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W
|
mFOLFOX-6 + Ramucirumab
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W
|
mFOLFOX-6 + Icrucumab
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Overall Study
STARTED
|
54
|
52
|
52
|
|
Overall Study
Received at Least One Dose of Study Drug
|
49
|
52
|
52
|
|
Overall Study
COMPLETED
|
46
|
52
|
49
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
3
|
Reasons for withdrawal
| Measure |
mFOLFOX-6
mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W)
Folinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid \[LFA\]: 200 mg/m² Q2 weeks if FA is unavailable).
Fluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W
|
mFOLFOX-6 + Ramucirumab
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W
|
mFOLFOX-6 + Icrucumab
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
3
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Met Exclusion Criteria
|
2
|
0
|
0
|
Baseline Characteristics
A Study of Ramucirumab or Icrucumab in Colorectal Cancer
Baseline characteristics by cohort
| Measure |
mFOLFOX-6
n=49 Participants
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=52 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=52 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 9.23 • n=93 Participants
|
59.9 years
STANDARD_DEVIATION 10.95 • n=4 Participants
|
58.2 years
STANDARD_DEVIATION 10.15 • n=27 Participants
|
59.6 years
STANDARD_DEVIATION 10.14 • n=483 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
71 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
82 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
152 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
125 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)Population: Modified Intent-to-Treatment (mITT) population includes all the randomized participants who received at least one dose study drug. In mFOLFOX-6, mFOLFOX-6+Ramucirumab and mFOLFOX-6 + Icrucumab, there were 13, 9 and 11 censored participants, respectively.
PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.
Outcome measures
| Measure |
mFOLFOX-6
n=49 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=52 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=52 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
18.4 Weeks
Interval 15.7 to 24.4
|
21.4 Weeks
Interval 16.1 to 25.0
|
15.9 Weeks
Interval 14.1 to 16.4
|
SECONDARY outcome
Timeframe: Baseline until Disease Progression (Up to 95 Weeks)Population: mITT population includes all the randomized participants who received at least one dose of study drug.
The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \[target or non-target\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.
Outcome measures
| Measure |
mFOLFOX-6
n=49 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=52 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=52 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
|
14 percentage of participants
Interval 5.94 to 27.24
|
3.8 percentage of participants
Interval 0.47 to 13.21
|
3.8 percentage of participants
Interval 0.47 to 13.21
|
SECONDARY outcome
Timeframe: Baseline Until Death from Any Cause (Up to 163 Weeks)Population: mITT population includes all the randomized participants who received at least one dose of study drug. In mFOLFOX-6, mFOLFOX-6 + Ramucirumab, and mFOLFOX-6 + Icrucumab there were 12, 11, and 12 censored participants, respectively.
Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.
Outcome measures
| Measure |
mFOLFOX-6
n=49 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=52 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=52 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Overall Survival (OS)
|
53.6 Weeks
Interval 36.1 to 68.4
|
41.7 Weeks
Interval 28.4 to 60.3
|
42.0 Weeks
Interval 32.0 to 50.4
|
SECONDARY outcome
Timeframe: Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)Population: mITT population includes all the randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline DoR data. 2 participants were censored in mFOLFOX-6 arm, 2 in mFOLFOX-6 + Ramucirumab arm and 1 in mFOLFOX-6 + Icrucumab.
DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to \< 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)
Outcome measures
| Measure |
mFOLFOX-6
n=7 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=2 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=2 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Duration of Response (DoR)
|
35.6 Weeks
Interval 4.0 to
NA= data not evaluable by Kaplan-Meier method due to sample size of participants
|
NA Weeks
N of 2 participants were censored therefore no evaluable data was collected.
|
NA Weeks
Interval 8.1 to
N of 1 participant was censored therefore only individual data is presented, 8.1 weeks.
|
SECONDARY outcome
Timeframe: Cycle 5, 1 Hour Post End of InfusionPopulation: All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable ramucirumab or icrucumab PK data to calculate Cmax.
Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.
Outcome measures
| Measure |
mFOLFOX-6
n=2 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=3 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
Geometric mean and Coefficient of Variation were not calculated because number of participants was \<3.
Values equal 12.900/54.5000 (min/max)
|
201 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 88
|
—
|
SECONDARY outcome
Timeframe: Cycle 5, Prior to InfusionPopulation: All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable Ramucirumab or Icrucumab PK data to calculate Ctrough.
Trough (prior to infusion, Ctrough) concentrations measured in serum.
Outcome measures
| Measure |
mFOLFOX-6
n=3 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=4 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5
|
53.6 µg/mL
Geometric Coefficient of Variation 123
|
146 µg/mL
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: Day 8 (cycles 1 and 5)Population: Zero participants analyzed. Outcome Measure (OM) entered incorrectly and no data collected to report.
Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15 (Cycles 1 and 5)Population: Zero participants analyzed. OM entered incorrectly and no data collected to report.
Cmax is the maximum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 (cycles 1, 5, 9, and 13)Population: Zero participants analyzed. OM entered incorrectly and no data collected to report.
Cmin is the minimum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 4 (cycles 1 and 5)Population: Zero participants analyzed. OM entered incorrectly and no data collected to report.
Cmin is the minimum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8 (cycles 1 and 5)Population: Zero participants analyzed. OM entered incorrectly and no data collected to report.
Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 15 (cycles 1 and 5)Population: Zero participants analyzed. OM entered incorrectly and no data collected to report.
Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 31 WeeksPopulation: Participants in mFOLFOX-6 +Ramucirumab who received at least one dose of study drug and had at least 1 post treatment assessment.
A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.
Outcome measures
| Measure |
mFOLFOX-6
n=52 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Number of Participants With Serum Ramucirumab Antibody Assessment
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 31 WeeksPopulation: Zero participants analyzed. No data collected to report.
A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 165 weeksPopulation: Population includes all the randomized participants who received at least one dose study drug.
A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
mFOLFOX-6
n=49 Participants
mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Ramucirumab
n=52 Participants
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV infusion Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
mFOLFOX-6 + Icrucumab
n=52 Participants
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W
FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Any TEAE
|
49 Participants
|
52 Participants
|
52 Participants
|
|
Number of Participants With Adverse Events
Any SAE
|
11 Participants
|
18 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events
Any Grade ≥3 AE
|
30 Participants
|
37 Participants
|
31 Participants
|
|
Number of Participants With Adverse Events
Any AE leading to discontinuation (any drug)
|
6 Participants
|
18 Participants
|
11 Participants
|
Adverse Events
mFOLFOX-6
Serious events: 11 serious events
Other events: 48 other events
Deaths: 37 deaths
mFOLFOX-6 + Ramucirumab
Serious events: 18 serious events
Other events: 52 other events
Deaths: 41 deaths
mFOLFOX-6 + Icrucumab
Serious events: 12 serious events
Other events: 52 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
mFOLFOX-6
n=49 participants at risk
mFOLFOX-6
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
mFOLFOX-6 + Ramucirumab
n=52 participants at risk
mFOLFOX-6 + Ramucirumab
Ramucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
mFOLFOX-6 + Icrucumab
n=52 participants at risk
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Infusion related reaction
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Neutropenic infection
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
mFOLFOX-6
n=49 participants at risk
mFOLFOX-6
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
mFOLFOX-6 + Ramucirumab
n=52 participants at risk
mFOLFOX-6 + Ramucirumab
Ramucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
mFOLFOX-6 + Icrucumab
n=52 participants at risk
mFOLFOX-6 + Icrucumab
Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks
mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks
FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
18.4%
9/49 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 33
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.7%
16/49 • Number of events 37
All randomized participants who received at least one dose of study drug.
|
30.8%
16/52 • Number of events 39
All randomized participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.5%
12/49 • Number of events 35
All randomized participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 37
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
26.5%
13/49 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
30.8%
16/52 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
46.2%
24/52 • Number of events 37
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
24.5%
12/49 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
34.6%
18/52 • Number of events 27
All randomized participants who received at least one dose of study drug.
|
36.5%
19/52 • Number of events 32
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.8%
19/49 • Number of events 53
All randomized participants who received at least one dose of study drug.
|
57.7%
30/52 • Number of events 54
All randomized participants who received at least one dose of study drug.
|
51.9%
27/52 • Number of events 68
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
2/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
7/49 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
61.2%
30/49 • Number of events 61
All randomized participants who received at least one dose of study drug.
|
46.2%
24/52 • Number of events 42
All randomized participants who received at least one dose of study drug.
|
69.2%
36/52 • Number of events 82
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
24.5%
12/49 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
36.5%
19/52 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
34.7%
17/49 • Number of events 31
All randomized participants who received at least one dose of study drug.
|
25.0%
13/52 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
51.9%
27/52 • Number of events 58
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
8.2%
4/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
25.0%
13/52 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
71.4%
35/49 • Number of events 86
All randomized participants who received at least one dose of study drug.
|
86.5%
45/52 • Number of events 91
All randomized participants who received at least one dose of study drug.
|
69.2%
36/52 • Number of events 106
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Infusion related reaction
|
10.2%
5/49 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
10.2%
5/49 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
28.8%
15/52 • Number of events 28
All randomized participants who received at least one dose of study drug.
|
55.8%
29/52 • Number of events 54
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
22.4%
11/49 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Temperature intolerance
|
42.9%
21/49 • Number of events 76
All randomized participants who received at least one dose of study drug.
|
25.0%
13/52 • Number of events 33
All randomized participants who received at least one dose of study drug.
|
34.6%
18/52 • Number of events 66
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
12.2%
6/49 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.2%
6/49 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
4.1%
2/49 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
14.3%
7/49 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
6.1%
3/49 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 50
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
14.3%
7/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
26.9%
14/52 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
6.1%
3/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.7%
16/49 • Number of events 29
All randomized participants who received at least one dose of study drug.
|
38.5%
20/52 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
51.9%
27/52 • Number of events 46
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.1%
2/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.1%
3/49 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
3/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.1%
2/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
7/49 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.2%
4/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.2%
5/49 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.2%
5/49 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
6.1%
3/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 27
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
32.7%
17/52 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.3%
8/49 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
30.8%
16/52 • Number of events 29
All randomized participants who received at least one dose of study drug.
|
17.3%
9/52 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
24.5%
12/49 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
23.1%
12/52 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
19.2%
10/52 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
4.1%
2/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
55.1%
27/49 • Number of events 94
All randomized participants who received at least one dose of study drug.
|
48.1%
25/52 • Number of events 72
All randomized participants who received at least one dose of study drug.
|
61.5%
32/52 • Number of events 81
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
14.3%
7/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
13.5%
7/52 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
19.2%
10/52 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.4%
9/49 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
30.8%
16/52 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
19.2%
10/52 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.2%
4/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
19.2%
10/52 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
30.8%
16/52 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.0%
1/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.2%
5/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
26.9%
14/52 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.2%
4/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.2%
5/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
6.1%
3/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
0.00%
0/52
All randomized participants who received at least one dose of study drug.
|
11.5%
6/52 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
7.7%
4/52 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
3/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
28.8%
15/52 • Number of events 22
All randomized participants who received at least one dose of study drug.
|
15.4%
8/52 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
1.9%
1/52 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
3.8%
2/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
5.8%
3/52 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
28.8%
15/52 • Number of events 24
All randomized participants who received at least one dose of study drug.
|
9.6%
5/52 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Compnay
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60