Trial Outcomes & Findings for A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer (NCT NCT02443883)
NCT ID: NCT02443883
Last Updated: 2020-06-29
Results Overview
The Cmin is the minimum observed serum concentration of ramucirumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Day 29, 43, 71 and 85: predose
Results posted on
2020-06-29
Participant Flow
Study completion was defined as death due to any cause or disease progression.
Participant milestones
| Measure |
Ramucirumab Regimen 1
Ramucirumab (8milligram per kilogram \[mg/kg\]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
42
|
41
|
41
|
|
Overall Study
Received at Least One Dose of Study Drug
|
38
|
42
|
41
|
40
|
|
Overall Study
COMPLETED
|
34
|
38
|
40
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
1
|
5
|
Reasons for withdrawal
| Measure |
Ramucirumab Regimen 1
Ramucirumab (8milligram per kilogram \[mg/kg\]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
|
Overall Study
Randomized, but never treated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer
Baseline characteristics by cohort
| Measure |
Ramucirumab Regimen 1
n=40 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=42 Participants
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=41 Participants
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=41 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 14.0 • n=93 Participants
|
58.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 12.3 • n=27 Participants
|
56.2 years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
58.5 years
STANDARD_DEVIATION 12.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
128 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
134 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
135 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Region of Enrollment
New Zealand
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Region of Enrollment
Argentina
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
|
Region of Enrollment
Romania
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Region of Enrollment
Hungary
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Region of Enrollment
Poland
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
|
Region of Enrollment
Slovakia
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Region of Enrollment
Russia
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 29, 43, 71 and 85: predosePopulation: All randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab PK data.
The Cmin is the minimum observed serum concentration of ramucirumab.
Outcome measures
| Measure |
Ramucirumab Regimen 1
n=38 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=42 Participants
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=41 Participants
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=40 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Day 29
|
32.9 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 51
|
59.5 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 60
|
69.3 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 45
|
71.6 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 37
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Day 43
|
47.6 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 36
|
71.0 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 58
|
83.0 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 57
|
57.4 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 44
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Day 71
|
60.4 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 34
|
65.0 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 60
|
122 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 65
|
97.1 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 46
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Day 85
|
64.3 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 40
|
79.4 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 46
|
125 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 56
|
81.6 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)Population: All randomized participants who received at least 1 dose of ramucirumab and had evaluable anti-ramucirumab antibody measurement.
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Outcome measures
| Measure |
Ramucirumab Regimen 1
n=19 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=26 Participants
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=20 Participants
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=22 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Immunogenicity: Number of Participants With Anti-Ramucirumab Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline until the first 6-week tumor assessmentPopulation: All randomized participants.Censored participants:Ramucirumab Regimen 1 = 8,Ramucirumab Regimen 2 =10,Ramucirumab Regimen 3=8 and Ramucirumab Regimen 4=12. PFS survival rate at the first 6-week assessment was estimated using the Kaplan-Meier method which takes into consideration who were censored prior to 6 weeks.
PFS defined as the time from first day of therapy to first evidence of disease progression per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) or death from any cause up to the first 6-week tumor assessment. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study and absolute increase of at least 5 mm.Appearance of 1 or more new lesions was also considered progression. Nontarget PD is unequivocal progression of existing nontarget lesions.Appearance of 1 or more new nontarget lesions was also considered PD.Participants with no baseline disease assessment: PFS time was censored at the randomization date,regardless of whether or not objectively determined disease progression or death has been observed.
Outcome measures
| Measure |
Ramucirumab Regimen 1
n=40 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=42 Participants
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=41 Participants
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=41 Participants
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment
|
43.9 Percentage of participants
Interval 27.3 to 59.3
|
61.9 Percentage of participants
Interval 44.9 to 75.0
|
53.0 Percentage of participants
Interval 36.2 to 67.3
|
51.2 Percentage of participants
Interval 34.2 to 65.9
|
Adverse Events
Ramucirumab Regimen 1
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Ramucirumab Regimen 2
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Ramucirumab Regimen 3
Serious events: 10 serious events
Other events: 36 other events
Deaths: 0 deaths
Ramucirumab Regimen 4
Serious events: 18 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab Regimen 1
n=38 participants at risk
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=42 participants at risk
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=41 participants at risk
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=40 participants at risk
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric perforation
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Thoracic cavity drainage
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Ramucirumab Regimen 1
n=38 participants at risk
Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 2
n=42 participants at risk
Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 3
n=41 participants at risk
Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
|
Ramucirumab Regimen 4
n=40 participants at risk
Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
4/38 • Number of events 12 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 15 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 11 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
6/38 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
23.8%
10/42 • Number of events 14 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.1%
7/41 • Number of events 9 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.1%
7/41 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
3/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
21.4%
9/42 • Number of events 12 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 9 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
6/38 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 9 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
6/38 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
19.5%
8/41 • Number of events 13 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 10 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/38 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 6 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
26.3%
10/38 • Number of events 12 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
28.6%
12/42 • Number of events 17 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
22.5%
9/40 • Number of events 9 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.5%
4/42 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
10.5%
4/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
9.8%
4/41 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
3/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
6/38 • Number of events 6 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.5%
4/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
11.9%
5/42 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
7.9%
3/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
7.9%
3/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.1%
8/38 • Number of events 11 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
21.4%
9/42 • Number of events 16 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
26.8%
11/41 • Number of events 13 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
2/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 6 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.5%
4/38 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.3%
3/41 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.9%
3/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.9%
3/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
6/42 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
12.2%
5/41 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/41 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/40 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
4/38 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
2/38 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 6 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
4/38 • Number of events 5 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
7.1%
3/42 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/38 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
14.6%
6/41 • Number of events 7 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.3%
2/38 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/42 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/41 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
2/38 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.4%
1/42 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.9%
2/41 • Number of events 2 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
15.8%
6/38 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
4.8%
2/42 • Number of events 3 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
17.1%
7/41 • Number of events 8 • Up To 3 Years and 3 Months
All randomized participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 10 • Up To 3 Years and 3 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: LTE60