Trial Outcomes & Findings for Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients (NCT NCT01234402)
NCT ID: NCT01234402
Last Updated: 2019-08-14
Results Overview
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Results posted on
2019-08-14
Participant Flow
Participants in Capecitabine arm were allowed to cross-over to ramucirumab or icrucumab in combination with capecitabine, after radiographic disease progression while on capecitabine.
Completers are those participants who died or alive and on study at conclusion but off treatment.
Participant milestones
| Measure |
Ramucirumab + Capecitabine
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
50
|
|
Overall Study
Received at Least One Dose of Study Drug
|
52
|
49
|
49
|
|
Overall Study
Capecitabine Crossover to Ramucirumab
|
0
|
0
|
29
|
|
Overall Study
Capecitabine Crossover to Icrucumab
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
51
|
45
|
42
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
8
|
Reasons for withdrawal
| Measure |
Ramucirumab + Capecitabine
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
4
|
|
Overall Study
Never treated: Death
|
0
|
0
|
1
|
|
Overall Study
Never treated: Withdrawal By Subject
|
0
|
1
|
0
|
|
Overall Study
Never treated: Insurance Denied Xeloda
|
0
|
1
|
0
|
Baseline Characteristics
Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native,White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White, Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)Population: All randomized participants who received at least one dose of study drug; Censored participants: Ramucirumab + Capecitabine = 12; Icrucumab + Capecitabine = 11; Capecitabine = 7
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
22.1 Weeks
Interval 12.1 to 36.1
|
7.3 Weeks
Interval 6.3 to 13.0
|
19.0 Weeks
Interval 12.1 to 24.3
|
SECONDARY outcome
Timeframe: From Date of Randomization until Death Due to Any Cause (Up To 160 weeks)Population: All randomized participants who received at least one dose of study drug; censored participants: Ramucirumab + Capecitabine = 21; Icrucumab + Capecitabine = 17; Capecitabine = 22 Participants were analyzed as per the randomization.
Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Overall Survival (OS)
|
67.4 Weeks
Interval 41.3 to 82.6
|
62.1 Weeks
Interval 41.0 to 84.0
|
71.6 Weeks
Interval 57.4 to 89.7
|
SECONDARY outcome
Timeframe: From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks)Population: All randomized participants who received at least one dose of study drug.
The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
28.8 Percentage of Participants
Interval 17.1 to 43.1
|
20.4 Percentage of Participants
Interval 10.2 to 34.3
|
34.7 Percentage of Participants
Interval 21.7 to 49.6
|
SECONDARY outcome
Timeframe: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks)Population: All randomized participants who received at least one dose of study drug and had CR/PR.
Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=15 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=10 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=17 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Duration of Response
|
43.1 weeks
Interval 12.0 to 49.0
|
20.1 weeks
Interval 1.9 to 33.9
|
17.1 weeks
Interval 6.4 to 30.7
|
SECONDARY outcome
Timeframe: Up To 160 WeeksPopulation: All randomized participants who received at least one dose of study drug.
Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
52 Participants
|
49 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up To 160 WeeksPopulation: All randomized participants who received at least one dose of study drug.
SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=52 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 Participants
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 Participants
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
20 Participants
|
25 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=11 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab
|
308 Microgram per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=12 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 22
|
55.0 Micro gram per milliliter
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 2
|
23.7 Micro gram per milliliter
Geometric Coefficient of Variation 58
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 4
|
80.6 Micro gram per milliliter
Geometric Coefficient of Variation 67
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 6
|
44.7 Micro gram per milliliter
Geometric Coefficient of Variation 83
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 8
|
65.8 Micro gram per milliliter
Geometric Coefficient of Variation 43
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 10
|
66.8 Micro gram per milliliter
Geometric Coefficient of Variation 37
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 12
|
74.3 Micro gram per milliliter
Geometric Coefficient of Variation 38
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 14
|
62.5 Micro gram per milliliter
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 16
|
50.5 Micro gram per milliliter
|
—
|
—
|
|
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Cycle 18
|
50.5 Micro gram per milliliter
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=7 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab
|
54400 microgram*hour/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Terminal half-life (t½) of Ramucirumab and Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=7 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Terminal Half-life (t½) of Ramucirumab or Icrucumab
|
6.80 Days
Interval 5.22 to 8.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Clearance (Cl) of Ramucirumab and Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=7 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Clearance (Cl) of Ramucirumab or Icrucumab
|
0.0141 Liters per hour
Geometric Coefficient of Variation 34
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, all randomized participants who received at least one dose of study drug \& had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples.
Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=11 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab
|
3.17 Liters
Geometric Coefficient of Variation 18
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusionPopulation: For ramucirumab, Aall randomized participants who received at least one dose of study drug and had evaluable serum samples for antibody assessment. For icrucumab, zero participants analyzed as antibody assessment data was not collected for Icrucumab.
Outcome measures
| Measure |
Ramucirumab + Capecitabine
n=43 Participants
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m\^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
Participants received 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab;
Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m\^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|
|
Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies
Treatment emergent antibody
|
0 Participants
|
—
|
—
|
|
Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies
Neutralizing antibody
|
0 Participants
|
—
|
—
|
Adverse Events
Ramucirumab + Capecitabine
Serious events: 20 serious events
Other events: 51 other events
Deaths: 0 deaths
Icrucumab + Capecitabine
Serious events: 25 serious events
Other events: 49 other events
Deaths: 0 deaths
Capecitabine
Serious events: 6 serious events
Other events: 48 other events
Deaths: 0 deaths
Crossover to Ramucirumab DP + Capecitabine
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Crossover to Icrucumab + Capecitabine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab + Capecitabine
n=52 participants at risk
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 participants at risk
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 participants at risk
Participants received 1000 mg/m\*2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Crossover to Ramucirumab DP + Capecitabine
n=29 participants at risk
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Crossover to Icrucumab + Capecitabine
n=1 participants at risk
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
16.3%
8/49 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Ramucirumab + Capecitabine
n=52 participants at risk
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Icrucumab + Capecitabine
n=49 participants at risk
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Capecitabine
n=49 participants at risk
Participants received 1000 mg/m\*2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Crossover to Ramucirumab DP + Capecitabine
n=29 participants at risk
Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
Crossover to Icrucumab + Capecitabine
n=1 participants at risk
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m\*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.5%
7/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
28.6%
14/49 • Number of events 35 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.5%
12/49 • Number of events 28 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
4/52 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 13 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.6%
5/52 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 15 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 15 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
8/52 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.3%
9/52 • Number of events 13 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 11 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
7.7%
4/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
5.8%
3/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Periorbital oedema
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.3%
9/52 • Number of events 11 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
3/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
34.6%
18/52 • Number of events 25 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
28.6%
14/49 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
34.7%
17/49 • Number of events 25 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.1%
7/29 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.3%
22/52 • Number of events 47 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
40.8%
20/49 • Number of events 38 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
55.1%
27/49 • Number of events 58 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
6/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
51.9%
27/52 • Number of events 47 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
75.5%
37/49 • Number of events 53 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
53.1%
26/49 • Number of events 39 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
27.6%
8/29 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
26.9%
14/52 • Number of events 20 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 12 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
36.5%
19/52 • Number of events 23 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
51.0%
25/49 • Number of events 31 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
28.6%
14/49 • Number of events 25 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.1%
7/29 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
11.5%
6/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 12 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
51.9%
27/52 • Number of events 54 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
55.1%
27/49 • Number of events 43 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
53.1%
26/49 • Number of events 36 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
37.9%
11/29 • Number of events 15 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
11.5%
6/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
15.4%
8/52 • Number of events 14 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
25.0%
13/52 • Number of events 21 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
38.8%
19/49 • Number of events 37 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
9.6%
5/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
26.9%
14/52 • Number of events 18 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
5/52 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
13.5%
7/52 • Number of events 13 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
4/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
4/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.8%
2/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
9.6%
5/52 • Number of events 12 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
17.3%
9/52 • Number of events 14 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
4/52 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 12 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.8%
3/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
7.7%
4/52 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
5.8%
3/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
3.8%
2/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.7%
17/52 • Number of events 26 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
22.4%
11/49 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
20.4%
10/49 • Number of events 17 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
20.7%
6/29 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.3%
9/52 • Number of events 15 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.7%
4/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.6%
5/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 22 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
13.8%
4/29 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.1%
12/52 • Number of events 18 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.5%
12/49 • Number of events 17 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.8%
3/52 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.2%
11/52 • Number of events 19 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
16.3%
8/49 • Number of events 13 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.2%
10/52 • Number of events 15 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
16.3%
8/49 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
20.7%
6/29 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.5%
6/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
2/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
13.5%
7/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.5%
6/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.3%
9/52 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.5%
6/52 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
28.8%
15/52 • Number of events 29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
11.5%
6/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
11.5%
6/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
50.0%
26/52 • Number of events 60 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 11 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
22.4%
11/49 • Number of events 18 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
44.8%
13/29 • Number of events 16 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
1.9%
1/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
19.2%
10/52 • Number of events 17 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.5%
6/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
11.5%
6/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
11.5%
6/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
12.2%
6/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
13.5%
7/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.5%
12/49 • Number of events 14 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
9.6%
5/52 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.4%
21/52 • Number of events 27 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
20.4%
10/49 • Number of events 11 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.5%
19/52 • Number of events 29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
32.7%
16/49 • Number of events 19 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.1%
7/29 • Number of events 11 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.3%
9/52 • Number of events 12 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
17.2%
5/29 • Number of events 7 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.6%
5/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.6%
5/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
9.6%
5/52 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.8%
3/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
18.4%
9/49 • Number of events 10 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.5%
6/52 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 6 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.8%
3/52 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
14.3%
7/49 • Number of events 9 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
71.2%
37/52 • Number of events 127 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
30.6%
15/49 • Number of events 38 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
71.4%
35/49 • Number of events 114 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
58.6%
17/29 • Number of events 40 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
2/52 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.3%
3/29 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
4/52 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 3 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.8%
3/52 • Number of events 13 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
13.5%
7/52 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
4.1%
2/49 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
3.8%
2/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.1%
3/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
1.9%
1/52 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/49 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
3.4%
1/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
30.8%
16/52 • Number of events 35 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
24.1%
7/29 • Number of events 8 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.9%
1/52 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
10.2%
5/49 • Number of events 5 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/29 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/52 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
2.0%
1/49 • Number of events 1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
8.2%
4/49 • Number of events 4 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
6.9%
2/29 • Number of events 2 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 160 Weeks
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on PI is for five years after the study conclusion/termination, after five years disclosure restriction on PI is that sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER