Trial Outcomes & Findings for A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma (NCT NCT02539225)
NCT ID: NCT02539225
Last Updated: 2022-03-08
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) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
191 participants
Primary outcome timeframe
Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)
Results posted on
2022-03-08
Participant Flow
Completers are defined as participants who died or those who were alive and off treatment at study completion.
Participant milestones
| Measure |
Ramucirumab + S-1 + Oxaliplatin
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Part A
STARTED
|
97
|
94
|
|
Part A
Received Any Quantity of Study Drug
|
96
|
93
|
|
Part A
COMPLETED
|
77
|
78
|
|
Part A
NOT COMPLETED
|
20
|
16
|
|
Pre Treatment for Part B
STARTED
|
63
|
66
|
|
Pre Treatment for Part B
COMPLETED
|
58
|
64
|
|
Pre Treatment for Part B
NOT COMPLETED
|
5
|
2
|
|
Part B
STARTED
|
58
|
64
|
|
Part B
COMPLETED
|
54
|
48
|
|
Part B
NOT COMPLETED
|
4
|
16
|
Reasons for withdrawal
| Measure |
Ramucirumab + S-1 + Oxaliplatin
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Part A
Adverse Event
|
13
|
4
|
|
Part A
Withdrawal by Subject
|
2
|
4
|
|
Part A
Physician Decision
|
4
|
7
|
|
Part A
Did Not Receive study Drug
|
1
|
1
|
|
Pre Treatment for Part B
Progressive disease
|
1
|
1
|
|
Pre Treatment for Part B
Adverse Event
|
1
|
1
|
|
Pre Treatment for Part B
Withdrawal by Subject
|
1
|
0
|
|
Pre Treatment for Part B
Physician Decision
|
2
|
0
|
|
Part B
Adverse Event
|
4
|
4
|
|
Part B
Withdrawal by Subject
|
0
|
3
|
|
Part B
Physician Decision
|
0
|
9
|
Baseline Characteristics
A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=96 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=93 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.2 Years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
60.2 Years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
96 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
96 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)Population: All randomized participants who received any quantity of study drug in Part A. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 23; Placebo + S-1 + Oxaliplatin = 19.
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) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=96 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=93 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
6.34 Months
Interval 5.65 to 6.93
|
6.74 Months
Interval 5.75 to 7.13
|
SECONDARY outcome
Timeframe: Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months)Population: All randomized participants who received any quantity of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 26; Placebo + S-1 + Oxaliplatin = 26.
Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=96 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=93 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Progression-free Survival to the Second Disease Progression (PFS 2)
|
10.94 Months
Interval 9.63 to 12.52
|
11.99 Months
Interval 9.82 to 13.83
|
SECONDARY outcome
Timeframe: Randomization to Death Due to Any Cause (Up to 31 Months)Population: All randomized participants who received at least one dose of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 27; Placebo + S-1 + Oxaliplatin = 30.
Overall survival is defined as time from the date of randomization to the date of death from any cause. If the patient was alive at the cut-off for analysis (or lost to follow-up), OS data were censored for analysis on the last date the patient was known to be alive.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=96 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=93 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Overall Survival (OS)
|
14.65 Months
Interval 12.39 to 15.67
|
14.26 Months
Interval 13.83 to 17.31
|
SECONDARY outcome
Timeframe: Randomization to Disease Progression (Up to 25 Months)Population: All randomized participants who received any quantity of study drug in Part A with measurable disease.
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 is defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR is 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 or the appearance of ≥1 new lesions was progression.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=55 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=54 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Percentage of Participants With Objective Response Rate (ORR)
|
58.2 percentage of participants
Interval 49.7 to 66.7
|
50.0 percentage of participants
Interval 41.3 to 58.7
|
SECONDARY outcome
Timeframe: Randomization to Disease Progression (Up to 25 Months)Population: All randomized participants who received any quantity of study drug in Part A with measurable disease.
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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 or the appearance of ≥1 new lesions was progression.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=55 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=54 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
90.9 percentage of participants
Interval 85.9 to 95.9
|
87 percentage of participants
Interval 81.2 to 92.9
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 PredosePopulation: All randomized participants who received at least one dose of ramucirumab in part A and had evaluable PK samples.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=96 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 1 Day 1
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Samples for Ramucirumab group at cycle 1 day 1 were below the limit of quantification and treated as missing for analysis.
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 2 Day 1
|
41.4 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 40
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 3 Day 1
|
59.4 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 51
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 5 Day 1
|
83.6 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 37
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 9 Day 1
|
94.6 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 38
|
—
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A
Cycle 1 Day 8
|
42.6 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 32
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 predose, Cycle 2 Day 1 predosePopulation: All randomized participants who received at least one dose of ramucirumab in part B and had evaluable PK samples.
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=58 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=64 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B
Cycle 1 Day 1
|
52.0 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 65
|
NA Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation NA
Samples for placebo group were below the limit of quantification and treated as missing for analysis
|
|
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B
Cycle 2 Day 1
|
58.1 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 40
|
41.0 Microgram per milliliter (ug/mL)
Geometric Coefficient of Variation 45
|
SECONDARY outcome
Timeframe: Baseline through 25 monthsPopulation: All randomized participants who received any quantity of study drug in part A and had at least one baseline \& post baseline antibody (ADA) measurement.
Participant is considered as treatment emergent anti-drug antibody (TE ADA) positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer \>= 20.
Outcome measures
| Measure |
Ramucirumab + S-1 + Oxaliplatin
n=92 Participants
Part A: Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin
n=90 Participants
Part A: Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
Part B:Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|
|
Number of Participants With Anti-Ramucirumab Antibodies
|
1 Participants
|
3 Participants
|
Adverse Events
Ramucirumab + S-1 + Oxaliplatin - Part A
Serious events: 29 serious events
Other events: 95 other events
Deaths: 2 deaths
Placebo + S-1 + Oxaliplatin - Part A
Serious events: 24 serious events
Other events: 93 other events
Deaths: 1 deaths
Ramucirumab + S-1 + Oxaliplatin Part B
Serious events: 16 serious events
Other events: 58 other events
Deaths: 1 deaths
Placebo + S-1 + Oxaliplatin - Part B
Serious events: 14 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ramucirumab + S-1 + Oxaliplatin - Part A
n=96 participants at risk
Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin - Part A
n=93 participants at risk
Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
|
Ramucirumab + S-1 + Oxaliplatin Part B
n=58 participants at risk
Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin - Part B
n=64 participants at risk
Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ileal perforation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Prepyloric stenosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Abdominal abscess
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Arthritis infective
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Mycobacterial infection
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Cerebral infarction
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Delirium
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal impairment
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
Ramucirumab + S-1 + Oxaliplatin - Part A
n=96 participants at risk
Participants received 8 milligram per kilogram (mg/kg) Ramucirumab by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin - Part A
n=93 participants at risk
Participants received placebo by intravenous (IV) infusion on day 1 and day 8 of 21 days cycle in combination with oral dose of 80-120 mg/day S-1 on days 1 to14 and 100 milligram per square meter (mg/m\^2) Oxaliplatin administered by IV infusion on day 1 until disease progression or any other discontinuation criteria is met.
|
Ramucirumab + S-1 + Oxaliplatin Part B
n=58 participants at risk
Participants received 8 mg/kg Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
Placebo + S-1 + Oxaliplatin - Part B
n=64 participants at risk
Participants received Ramucirumab by intravenous infusion on day 1 and day 15 of 28 days cycle in combination with 80 mg/m\^2 Paclitaxel on day 1, 8 and 15 by intravenous infusion until disease progression or any other discontinuation criteria is met.
|
|---|---|---|---|---|
|
General disorders
Tenderness
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.0%
25/96 • Number of events 37 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.5%
20/93 • Number of events 32 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.9%
15/58 • Number of events 19 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
17.2%
11/64 • Number of events 23 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.1%
3/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
6/96 • Number of events 17 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 20 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
5/96 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
2.1%
2/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
1/34 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Eustachian tube patulous
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Endocrine disorders
Hypothyroidism
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Cataract
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Conjunctivitis allergic
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Corneal erosion
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye discharge
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Hyalosis asteroid
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Iridocyclitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Keratitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
5.2%
5/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Panophthalmitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Periorbital oedema
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Ulcerative keratitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
6/96 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.5%
11/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.8%
11/93 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
18/96 • Number of events 26 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
22.6%
21/93 • Number of events 28 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.1%
7/58 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
9/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.8%
5/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Anal inflammation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
7.3%
7/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.8%
5/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
34.4%
33/96 • Number of events 52 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
32.3%
30/93 • Number of events 32 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.4%
6/64 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dental caries
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.0%
49/96 • Number of events 103 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
30.1%
28/93 • Number of events 62 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
17.2%
10/58 • Number of events 15 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
8/64 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
3/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.2%
4/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gingival pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.2%
5/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ileus
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Lip pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
4.2%
4/96 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
56.2%
54/96 • Number of events 90 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
39.8%
37/93 • Number of events 69 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Oral pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Periodontal disease
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Proctalgia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Regurgitation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Salivary gland fistula
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
28.1%
27/96 • Number of events 48 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
19.4%
18/93 • Number of events 25 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.5%
9/58 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.1%
9/64 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
4/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
29.2%
28/96 • Number of events 49 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
22.6%
21/93 • Number of events 34 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.9%
7/64 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Asthenia
|
3.1%
3/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.8%
5/64 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Axillary pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Catheter site pain
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chills
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Face oedema
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
29.2%
28/96 • Number of events 35 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
23.7%
22/93 • Number of events 35 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.1%
7/58 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
8/64 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling cold
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling hot
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Gait disturbance
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Impaired healing
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Influenza like illness
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Infusion site extravasation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Infusion site pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injection site pain
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injection site reaction
|
6.2%
6/96 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
8/93 • Number of events 17 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Injury associated with device
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Localised oedema
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Malaise
|
27.1%
26/96 • Number of events 35 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.5%
20/93 • Number of events 25 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.5%
9/58 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.9%
7/64 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Medical device site pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Nodule
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
2.1%
2/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Oedema
|
4.2%
4/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
27.1%
26/96 • Number of events 31 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.4%
19/93 • Number of events 24 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
13.8%
8/58 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
8/64 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pain
|
8.3%
8/96 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Peripheral swelling
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
22.9%
22/96 • Number of events 28 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
23.7%
22/93 • Number of events 43 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.1%
7/58 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
17.2%
11/64 • Number of events 15 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Sensation of foreign body
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Actinomycosis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Angular cheilitis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Conjunctivitis
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Eye infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes ophthalmic
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Infection
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Influenza
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Lip infection
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Localised infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Lung infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Mucosal infection
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Mycobacterial infection
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Nail infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
5/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.9%
4/58 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Periodontitis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
3.1%
3/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Purulence
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Skin infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
8/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urethritis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
3/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Wound infection
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.0%
1/96 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Stoma site discharge
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
21.9%
21/96 • Number of events 32 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.9%
12/93 • Number of events 18 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.9%
4/58 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Amylase increased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
26.0%
25/96 • Number of events 45 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.1%
15/93 • Number of events 26 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.4%
10/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.5%
7/93 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.7%
9/93 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
3.1%
3/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Endoscopic retrograde cholangiopancreatography
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.3%
7/96 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Hepatic enzyme increased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Lipase increased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Lymphocyte count decreased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
50.0%
48/96 • Number of events 156 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
34.4%
32/93 • Number of events 79 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
56.9%
33/58 • Number of events 85 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
56.2%
36/64 • Number of events 108 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Peritoneal effluent erythrocyte count increased
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
34.4%
33/96 • Number of events 67 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
30.1%
28/93 • Number of events 62 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.9%
4/58 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Weight decreased
|
11.5%
11/96 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.7%
9/93 • Number of events 18 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.9%
7/64 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Weight increased
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
White blood cell count decreased
|
25.0%
24/96 • Number of events 74 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
19.4%
18/93 • Number of events 58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
32.8%
19/58 • Number of events 49 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
24/64 • Number of events 59 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
55.2%
53/96 • Number of events 78 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
61.3%
57/93 • Number of events 90 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.5%
9/58 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
18.8%
12/64 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.1%
2/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.5%
7/93 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
6/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.5%
11/96 • Number of events 14 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.8%
11/93 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.3%
6/58 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.6%
10/64 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
3/96 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
4/96 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.3%
6/58 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
6/96 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
4/96 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.5%
7/93 • Number of events 9 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
8/96 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.8%
10/93 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
4/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.9%
4/58 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.9%
7/64 • Number of events 15 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
6/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
2.6%
1/39 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.5%
7/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
7.3%
7/96 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
21.9%
21/96 • Number of events 24 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.5%
20/93 • Number of events 20 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
5/58 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
16.7%
16/96 • Number of events 29 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.9%
12/93 • Number of events 21 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Hypersomnia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Hypoaesthesia
|
5.2%
5/96 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.3%
7/96 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Paralysis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
58.3%
56/96 • Number of events 88 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
75.3%
70/93 • Number of events 120 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
13.8%
8/58 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.9%
14/64 • Number of events 14 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
10.4%
10/96 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.8%
10/93 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.3%
6/58 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Cystitis noninfective
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
5.2%
5/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Proteinuria
|
26.0%
25/96 • Number of events 40 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.1%
14/93 • Number of events 25 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.3%
6/58 • Number of events 14 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.9%
7/64 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Ureteric stenosis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.8%
1/57 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Penile oedema
|
1.8%
1/57 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Penile pain
|
1.8%
1/57 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
2.6%
1/39 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
1/29 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
2.6%
1/39 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
7/96 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.8%
10/93 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.8%
5/64 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.2%
4/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
24/96 • Number of events 34 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.5%
6/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
17.2%
10/58 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.9%
14/64 • Number of events 22 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.2%
6/96 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural adhesion
|
1.0%
1/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
5/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
8/93 • Number of events 12 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.2%
5/96 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.4%
10/96 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
44.8%
26/58 • Number of events 26 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
46.9%
30/64 • Number of events 30 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Cutaneous symptom
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
10/96 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 5 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.2%
4/64 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.6%
15/96 • Number of events 16 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.5%
7/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
9/96 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.4%
5/93 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.2%
3/58 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.4%
6/64 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.6%
8/93 • Number of events 10 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
3/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.9%
4/58 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
17.7%
17/96 • Number of events 17 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.1%
15/93 • Number of events 15 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
2/64 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Cell-free and concentrated ascites reinfusion therapy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Cerebrospinal fluid reservoir placement
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Colostomy
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Gastroenterostomy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Gastrointestinal tube insertion
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 4 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Haematoma evacuation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Laparoscopic surgery
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Laparotomy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Oesophageal dilation procedure
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Omental flap operation
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Omental implantation
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Salpingo-oophorectomy bilateral
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
1/29 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Small intestinal intussusception reduction
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Stent placement
|
2.1%
2/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Suture insertion
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Thoracic cavity drainage
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Tooth extraction
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
3.1%
3/96 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Embolism
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.4%
2/58 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Flushing
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.2%
2/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Haematoma
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Haemorrhage
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
1.0%
1/96 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
29.2%
28/96 • Number of events 28 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.9%
12/93 • Number of events 13 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.7%
1/58 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
15.6%
10/64 • Number of events 11 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 6 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/96 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Vascular pain
|
3.1%
3/96 • Number of events 7 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
3/93 • Number of events 3 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/64 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Vasculitis
|
2.1%
2/96 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.3%
4/93 • Number of events 8 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/58 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
1/64 • Number of events 2 • Up to 31 Months
All randomized participants who received at least one dose of study drug. Adverse events data for pre-treatment Part B were included in part A. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60