Trial Outcomes & Findings for A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer (NCT NCT02514551)
NCT ID: NCT02514551
Last Updated: 2020-06-17
Results Overview
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Results posted on
2020-06-17
Participant Flow
Completers are defined as participants who died or had progressive disease (PD) or completed treatment or did not complete treatment and were followed for survival data. Final study data will be provided after study completion.
Participant milestones
| Measure |
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
122
|
|
Overall Study
Received at Least One Dose of Study Drug
|
123
|
120
|
|
Overall Study
COMPLETED
|
123
|
119
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
12 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 milligram per square meter (mg/m²) paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Participant Never Treated
|
0
|
2
|
Baseline Characteristics
A Study of Ramucirumab (LY3009806) in Combination With Paclitaxel in Participants With Gastric Cancer
Baseline characteristics by cohort
| Measure |
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=122 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
23 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Objective Progressive Disease or Death (Up To 21 Months)Population: All randomized participants in arm 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel. Number of participants censored: Ramucirumab 12 mg/kg + 80 mg/m² Paclitaxel= 25. All randomized participants (including the censored participants) were included in the analyses.
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ
|
5.42 months
Interval 4.4 to 6.01
|
—
|
SECONDARY outcome
Timeframe: Randomization to Objective Progressive Disease or Death (Up To 21 Months)Population: All randomized participants. Number of participants censored: Ramucirumab 12 mg/kg + Paclitaxel 80 mg/m2= 25 and 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel =23. All randomized participants (including the censored participants) were included in the analyses.
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=122 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ
|
5.42 months
Interval 4.4 to 6.01
|
5.16 months
Interval 3.81 to 5.65
|
SECONDARY outcome
Timeframe: Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOIPopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=103 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=95 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 1 Day 15 (Week 2)
|
39.2 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 43
|
21.4 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 58
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 2 Day 1 (Week 4)
|
63.6 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 40
|
37.1 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 50
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 2 Day 15 (Week 6)
|
76.7 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 42
|
43.5 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 53
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 3 Day 1(Week 8)
|
91.2 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 40
|
51.5 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 55
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 3 Day 15 (Week 10)
|
99.0 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 44
|
52.9 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 56
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Cycle 4 Day 1 (Week 12)
|
101 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 55
|
56.1 Microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 56
|
SECONDARY outcome
Timeframe: Baseline to Objective Progressive Disease (Up To 21 Months)Population: All randomized participants.
ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=122 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
|
27.6 percentage of participants
|
25.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Objective Progressive Disease (Up To 21 Months)Population: All randomized participants.
DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is 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 relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants\*100.
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=122 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]
|
78.9 percentage of participants
|
75.4 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Predose through Follow-up (Up To 24 Months)Population: All randomized participants who received at least one dose of study drug and were evaluable for ramucirumab anti-drug antibody.
Participants who had anti-ramucirumab antibodies at postbaseline.
Outcome measures
| Measure |
I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=105 Participants
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=89 Participants
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Number of Participants With Anti-Ramucirumab Antibodies
|
2 Participants
|
1 Participants
|
Adverse Events
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
Serious events: 47 serious events
Other events: 117 other events
Deaths: 81 deaths
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
Serious events: 32 serious events
Other events: 115 other events
Deaths: 76 deaths
Serious adverse events
| Measure |
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 participants at risk
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=120 participants at risk
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
Infections and infestations
Enteritis infectious
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
1.6%
2/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
3/123 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
3/120 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
4/123 • Number of events 4 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
3/120 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
4/123 • Number of events 5 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
1.7%
2/120 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
2.4%
3/123 • Number of events 6 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
2/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
1.7%
2/120 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
3/123 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
1.6%
2/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Death
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
1.6%
2/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Localised oedema
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Organ failure
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
1.6%
2/123 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
1.6%
2/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
4.9%
6/123 • Number of events 6 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.81%
1/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
1/123 • Number of events 2 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/123 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.83%
1/120 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.81%
1/123 • Number of events 1 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/120 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=123 participants at risk
12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
n=120 participants at risk
8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15.
|
|---|---|---|
|
General disorders
Asthenia
|
12.2%
15/123 • Number of events 35 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
15.8%
19/120 • Number of events 49 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
35.0%
43/123 • Number of events 85 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
38.3%
46/120 • Number of events 82 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.1%
10/123 • Number of events 11 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
13.3%
16/120 • Number of events 22 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
7.3%
9/123 • Number of events 10 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
6.7%
8/120 • Number of events 8 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
14/123 • Number of events 27 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
5.8%
7/120 • Number of events 8 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
16.3%
20/123 • Number of events 43 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
6.7%
8/120 • Number of events 15 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
9/123 • Number of events 25 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
8.3%
10/120 • Number of events 14 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
6.5%
8/123 • Number of events 12 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
1.7%
2/120 • Number of events 3 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
24.4%
30/123 • Number of events 91 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
20.0%
24/120 • Number of events 60 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
7.3%
9/123 • Number of events 15 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
5.8%
7/120 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
11.4%
14/123 • Number of events 16 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
10.8%
13/120 • Number of events 17 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
10.6%
13/123 • Number of events 33 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
11.7%
14/120 • Number of events 35 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.3%
25/123 • Number of events 41 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
26.7%
32/120 • Number of events 58 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.5%
8/123 • Number of events 18 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
9.2%
11/120 • Number of events 20 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.1%
10/123 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
11.7%
14/120 • Number of events 34 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.7%
7/123 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
5.8%
7/120 • Number of events 8 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
8/123 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
4.2%
5/120 • Number of events 5 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
10/123 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
9/120 • Number of events 14 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
11/123 • Number of events 18 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
9/120 • Number of events 16 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
4.1%
5/123 • Number of events 5 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
9/120 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
8.1%
10/123 • Number of events 12 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
9/120 • Number of events 12 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.2%
15/123 • Number of events 38 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
15/120 • Number of events 22 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
10.6%
13/123 • Number of events 30 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
10.8%
13/120 • Number of events 29 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
8/123 • Number of events 15 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
16.7%
20/120 • Number of events 46 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
7.3%
9/123 • Number of events 19 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
6.7%
8/120 • Number of events 11 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
14/123 • Number of events 17 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
6.7%
8/120 • Number of events 11 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.9%
11/123 • Number of events 15 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
6/120 • Number of events 7 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
4/123 • Number of events 5 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
12/120 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.1%
26/123 • Number of events 43 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
23.3%
28/120 • Number of events 36 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
19/123 • Number of events 19 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
20.0%
24/120 • Number of events 28 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.6%
34/123 • Number of events 72 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
32.5%
39/120 • Number of events 77 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.3%
9/123 • Number of events 44 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
9/120 • Number of events 18 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.9%
22/123 • Number of events 78 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
20.0%
24/120 • Number of events 62 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
7/123 • Number of events 10 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
3.3%
4/120 • Number of events 5 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
7/123 • Number of events 9 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
6/120 • Number of events 8 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.3%
20/123 • Number of events 31 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
15.8%
19/120 • Number of events 22 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
8/123 • Number of events 13 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
12/120 • Number of events 16 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
7.3%
9/123 • Number of events 11 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
4.2%
5/120 • Number of events 8 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
18.7%
23/123 • Number of events 33 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
21/120 • Number of events 27 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.2%
31/123 • Number of events 78 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
29.2%
35/120 • Number of events 65 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
8.9%
11/123 • Number of events 12 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
3.3%
4/120 • Number of events 4 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
22.0%
27/123 • Number of events 52 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
31.7%
38/120 • Number of events 95 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
15/123 • Number of events 19 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
15.0%
18/120 • Number of events 41 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
23.6%
29/123 • Number of events 51 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
22.5%
27/120 • Number of events 44 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
19.5%
24/123 • Number of events 44 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
21/120 • Number of events 46 • Up To 40 Months
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60