Trial Outcomes & Findings for Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma (NCT NCT01282463)
NCT ID: NCT01282463
Last Updated: 2019-09-09
Results Overview
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
Results posted on
2019-09-09
Participant Flow
Participants who died or discontinued treatment due to progressive disease (PD) were considered completers at the end of study. 8 participants were included in the "never treated" group due to death, PD, withdrawal, physician decision or protocol violation.
Participant milestones
| Measure |
Docetaxel
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
50
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
45
|
46
|
49
|
|
Overall Study
COMPLETED
|
41
|
45
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
4
|
Reasons for withdrawal
| Measure |
Docetaxel
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
3
|
|
Overall Study
Never Treated "Death"
|
0
|
1
|
0
|
|
Overall Study
Never Treated "PD"
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
Baseline characteristics by cohort
| Measure |
Docetaxel
n=45 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 9.06 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 10.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomization to Measured PD or Death From Any Cause (Up To 40 Months)Population: All randomized participants who received at least one dose of study drug. Participants censored: docetaxel arm = 40; docetaxel and ramucirumab arm = 34; docetaxel and Icrucumab arm = 41.
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Outcome measures
| Measure |
Docetaxel
n=45 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
2.8 months
Interval 1.9 to 3.6
|
5.4 months
Interval 3.1 to 6.9
|
1.6 months
Interval 1.4 to 5.4
|
SECONDARY outcome
Timeframe: Randomization to Measured PD (Up to 40 Months)Population: All randomized participants who received one dose of study drug.
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.
Outcome measures
| Measure |
Docetaxel
n=45 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Percentage of Participants Achieving Objective Response Rate (ORR)
|
8.9 percentage of participants
Interval 2.5 to 21.2
|
23.9 percentage of participants
Interval 12.6 to 38.8
|
12.2 percentage of participants
Interval 4.6 to 24.8
|
SECONDARY outcome
Timeframe: First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)Population: All randomized participants received one dose of study drug and had CR or PR.
The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Docetaxel
n=4 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=11 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=6 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Duration of Response
|
4.6 months
Interval 2.6 to 5.6
|
4.6 months
Interval 0.7 to 7.0
|
NA months
Interval 2.9 to
The median and the upper limit was not estimable due to a small sample size and 2 participants had PD or Death.
|
SECONDARY outcome
Timeframe: Up To 41.7 MonthsPopulation: All randomized participants who received at least one dose of study drug.
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Docetaxel
n=45 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE
|
45 Participants
|
46 Participants
|
49 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any SAE
|
19 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOIPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.
Outcome measures
| Measure |
Docetaxel
n=8 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Cycle 2
|
304 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
|
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Cycle 3
|
300 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 13
|
—
|
—
|
|
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Cycle 4
|
279 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
|
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Cycle 6
|
252 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 57
|
—
|
—
|
|
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Cycle 1
|
258 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOIPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.
Outcome measures
| Measure |
Docetaxel
n=46 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
PK: Minimum Concentration (Cmin) Ramucirumab
Cycle 2
|
19.5 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 56
|
—
|
—
|
|
PK: Minimum Concentration (Cmin) Ramucirumab
Cycle 3
|
39.9 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
PK: Minimum Concentration (Cmin) Ramucirumab
Cycle 4
|
35.3 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 60
|
—
|
—
|
|
PK: Minimum Concentration (Cmin) Ramucirumab
Cycle 6
|
31.2 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 61
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOIPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.
Outcome measures
| Measure |
Docetaxel
n=10 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
PK: Cmax Icrucumab
Cycle 3 Cmax
|
599 ug/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
|
PK: Cmax Icrucumab
Cycle 1 Cmax
|
474 ug/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOIPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.
Outcome measures
| Measure |
Docetaxel
n=10 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
PK: Cmin Icrucumab
Day 1 Cycle 2
|
NA ug/mL
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation was not calculable due to n=1.
|
—
|
—
|
|
PK: Cmin Icrucumab
Day 1 Cycle 3
|
153 ug/mL
Geometric Coefficient of Variation 66
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOIPopulation: All randomized participants who received at least one dose of study drug and had baseline and post baseline anti-ramucirumab antibodies.
Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. 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 |
Docetaxel
n=43 Participants
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Number of Participants With Serum Anti-Ramucirumab Antibody Assessment
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Day 8 Predose and 1hr Post DosePopulation: Zero participants analyzed. Data not collected.
A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 40 monthsPopulation: Zero participants analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 40 monthsPopulation: Zero participants analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 40 monthsPopulation: Zero participants analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 40 monthsPopulation: Zero participants analyzed. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 40 monthsPopulation: Zero participants analyzed. Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel
Serious events: 19 serious events
Other events: 45 other events
Deaths: 0 deaths
Docetaxel + Ramucirumab DP
Serious events: 25 serious events
Other events: 46 other events
Deaths: 0 deaths
Docetaxel + Icrucumab
Serious events: 22 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=45 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
5/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.4%
2/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Device occlusion
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Local swelling
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Multi-organ failure
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Arteritis infective
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
2.2%
1/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Eye infection staphylococcal
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Klebsiella sepsis
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
2.2%
1/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • 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)
Malignant pleural effusion
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Docetaxel
n=45 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
|
Docetaxel + Ramucirumab DP
n=46 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
|
Docetaxel + Icrucumab
n=49 participants at risk
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
10/45 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
23.9%
11/46 • Number of events 44
All randomized participants who received at least one dose of study drug.
|
40.8%
20/49 • Number of events 49
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.4%
2/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.4%
11/45 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
26.5%
13/49 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.9%
4/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
17.4%
8/46 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
6.7%
3/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
26.1%
12/46 • Number of events 18
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
21.7%
10/46 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
9/45 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
30.6%
15/49 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
11/45 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
54.3%
25/46 • Number of events 44
All randomized participants who received at least one dose of study drug.
|
44.9%
22/49 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
3/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
3/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
12/45 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
52.2%
24/46 • Number of events 36
All randomized participants who received at least one dose of study drug.
|
49.0%
24/49 • Number of events 40
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
15.6%
7/45 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
32.6%
15/46 • Number of events 29
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
7/45 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
30.4%
14/46 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
28.6%
14/49 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
4.4%
2/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
13.0%
6/46 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
11.1%
5/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
15.2%
7/46 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
80.0%
36/45 • Number of events 63
All randomized participants who received at least one dose of study drug.
|
82.6%
38/46 • Number of events 108
All randomized participants who received at least one dose of study drug.
|
77.6%
38/49 • Number of events 135
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
8.9%
4/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
21.7%
10/46 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
20.0%
9/45 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
37.0%
17/46 • Number of events 27
All randomized participants who received at least one dose of study drug.
|
49.0%
24/49 • Number of events 49
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
11.1%
5/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
23.9%
11/46 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
22.4%
11/49 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
6.7%
3/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
9/45 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
11.1%
5/45 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
15.6%
7/45 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
13.0%
6/46 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
15.2%
7/46 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
13.3%
6/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.2%
19/45 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
56.5%
26/46 • Number of events 39
All randomized participants who received at least one dose of study drug.
|
51.0%
25/49 • Number of events 41
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
6/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
20.4%
10/49 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
3/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.4%
11/45 • Number of events 20
All randomized participants who received at least one dose of study drug.
|
23.9%
11/46 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
24.5%
12/49 • Number of events 17
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.6%
7/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
13.0%
6/46 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 9
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
17.4%
8/46 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
6/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
26.1%
12/46 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
15.2%
7/46 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 10
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
17.4%
8/46 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
20.4%
10/49 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
37.8%
17/45 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
30.4%
14/46 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
32.7%
16/49 • Number of events 32
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
19.6%
9/46 • Number of events 13
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
13.3%
6/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
23.9%
11/46 • Number of events 21
All randomized participants who received at least one dose of study drug.
|
16.3%
8/49 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
13.3%
6/45 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
15.2%
7/46 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
6/45 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
15.2%
7/46 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
21.7%
10/46 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
34.7%
17/49 • Number of events 26
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
4.4%
2/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
32.6%
15/46 • Number of events 37
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
2.2%
1/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
2.9%
1/35 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
8.1%
3/37 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
4/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
39.1%
18/46 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
32.7%
16/49 • Number of events 19
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
24.4%
11/45 • Number of events 14
All randomized participants who received at least one dose of study drug.
|
26.1%
12/46 • Number of events 16
All randomized participants who received at least one dose of study drug.
|
32.7%
16/49 • Number of events 25
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
43.5%
20/46 • Number of events 23
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
13.0%
6/46 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
5/45 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
21.7%
10/46 • Number of events 11
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.9%
22/45 • Number of events 28
All randomized participants who received at least one dose of study drug.
|
58.7%
27/46 • Number of events 34
All randomized participants who received at least one dose of study drug.
|
53.1%
26/49 • Number of events 30
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 7
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
0.00%
0/46
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/45
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.7%
3/45 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
10.9%
5/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
8.9%
4/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
4.3%
2/46 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
8.7%
4/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
3/45 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.2%
1/46 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.4%
2/45 • Number of events 2
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.8%
8/45 • Number of events 12
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
2.2%
1/45 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
6.5%
3/46 • Number of events 4
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
6.7%
3/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
21.7%
10/46 • Number of events 15
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
11.1%
5/45 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
17.4%
8/46 • Number of events 8
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3
All randomized participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60