Trial Outcomes & Findings for A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (NCT NCT02060188)
NCT ID: NCT02060188
Last Updated: 2025-11-06
Results Overview
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
385 participants
Primary outcome timeframe
From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Cohort 1: Nivolumab Monotherapy
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
Nivolumab FD + Daratumumab 16 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
119
|
45
|
10
|
10
|
3
|
30
|
50
|
44
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
74
|
119
|
45
|
10
|
10
|
3
|
30
|
50
|
44
|
Reasons for withdrawal
| Measure |
Cohort 1: Nivolumab Monotherapy
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
Nivolumab FD + Daratumumab 16 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
36
|
42
|
8
|
5
|
6
|
3
|
23
|
20
|
43
|
|
Overall Study
Study Drug Toxicity
|
10
|
18
|
7
|
4
|
3
|
0
|
2
|
5
|
0
|
|
Overall Study
Adverse event unrelated to study drug
|
2
|
5
|
6
|
0
|
1
|
0
|
4
|
4
|
1
|
|
Overall Study
Participant request to discontinue study treatment
|
7
|
7
|
4
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Participant withdrew consent
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Maximum clinical benefit
|
13
|
38
|
19
|
0
|
0
|
0
|
0
|
10
|
0
|
|
Overall Study
Other reason
|
3
|
7
|
0
|
1
|
0
|
0
|
0
|
9
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Administrative reasons by sponsor
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
Baseline characteristics by cohort
| Measure |
Cohort 1: Nivolumab Monotherapy
n=74 Participants
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=119 Participants
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=45 Participants
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=10 Participants
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=10 Participants
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
n=3 Participants
Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
n=30 Participants
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
n=50 Participants
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
n=44 Participants
Nivolumab FD + Daratumumab 16 mg/kg
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
57 Participants
|
81 Participants
n=16 Participants
|
22 Participants
n=30 Participants
|
9 Participants
n=28 Participants
|
9 Participants
n=40 Participants
|
3 Participants
n=1 Participants
|
21 Participants
n=1673 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=10 Participants
|
268 Participants
n=14 Participants
|
|
Age, Customized
>= 65 and < 75 years
|
13 Participants
|
27 Participants
n=16 Participants
|
10 Participants
n=30 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
9 Participants
n=1673 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=10 Participants
|
80 Participants
n=14 Participants
|
|
Age, Customized
>= 75 years
|
4 Participants
|
11 Participants
n=16 Participants
|
13 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1673 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=10 Participants
|
37 Participants
n=14 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
|
49 Participants
n=16 Participants
|
22 Participants
n=30 Participants
|
2 Participants
n=28 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=1 Participants
|
12 Participants
n=1673 Participants
|
22 Participants
n=7 Participants
|
14 Participants
n=10 Participants
|
155 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
|
70 Participants
n=16 Participants
|
23 Participants
n=30 Participants
|
8 Participants
n=28 Participants
|
7 Participants
n=40 Participants
|
2 Participants
n=1 Participants
|
18 Participants
n=1673 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=10 Participants
|
230 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
|
110 Participants
n=16 Participants
|
43 Participants
n=30 Participants
|
10 Participants
n=28 Participants
|
10 Participants
n=40 Participants
|
3 Participants
n=1 Participants
|
23 Participants
n=1673 Participants
|
49 Participants
n=7 Participants
|
41 Participants
n=10 Participants
|
354 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
|
2 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=1673 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=10 Participants
|
16 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
|
3 Participants
n=16 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1673 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
|
3 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=1673 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=14 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1673 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)Population: All treated participants.
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments \\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cohort 1: Nivolumab Monotherapy
n=74 Participants
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=119 Participants
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=45 Participants
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
n=30 Participants
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
n=50 Participants
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
n=44 Participants
Nivolumab FD + Daratumumab 16 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
n=10 Participants
Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=10 Participants
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=3 Participants
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
|
40.5 percentage of participants
Interval 29.3 to 52.6
|
66.4 percentage of participants
Interval 57.2 to 74.8
|
71.1 percentage of participants
Interval 55.7 to 83.6
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
50.0 percentage of participants
Interval 35.5 to 64.5
|
0 percentage of participants
Interval 0.0 to 8.0
|
10.0 percentage of participants
Interval 0.5 to 39.4
|
0 percentage of participants
Interval 0.0 to 25.9
|
0 percentage of participants
Interval 0.0 to 63.2
|
SECONDARY outcome
Timeframe: From date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 127 months)Population: All treated participants. As pre-specified only applicable for Cohort 1, 2, 3, 4, 5 and 6
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on IRC\\\[using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\\\], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cohort 1: Nivolumab Monotherapy
n=74 Participants
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=119 Participants
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=45 Participants
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
n=30 Participants
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
n=50 Participants
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
n=44 Participants
Nivolumab FD + Daratumumab 16 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Independent Review Committee (IRC)
|
37.8 percentage of participants
Interval 26.8 to 49.9
|
61.3 percentage of participants
Interval 52.0 to 70.1
|
62.2 percentage of participants
Interval 46.5 to 76.2
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
50.0 percentage of participants
Interval 35.5 to 64.5
|
0 percentage of participants
Interval 0.0 to 8.0
|
—
|
—
|
—
|
Adverse Events
MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Serious events: 8 serious events
Other events: 10 other events
Deaths: 9 deaths
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
Serious events: 9 serious events
Other events: 10 other events
Deaths: 10 deaths
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
Serious events: 20 serious events
Other events: 27 other events
Deaths: 29 deaths
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
Serious events: 28 serious events
Other events: 48 other events
Deaths: 27 deaths
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
Serious events: 29 serious events
Other events: 43 other events
Deaths: 43 deaths
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
Serious events: 22 serious events
Other events: 45 other events
Deaths: 16 deaths
Cohort 1: Nivolumab Monotherapy
Serious events: 46 serious events
Other events: 73 other events
Deaths: 44 deaths
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
Serious events: 72 serious events
Other events: 116 other events
Deaths: 46 deaths
Serious adverse events
| Measure |
MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=10 participants at risk
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
n=3 participants at risk
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=10 participants at risk
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
n=30 participants at risk
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
n=50 participants at risk
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
n=44 participants at risk
Nivolumab FD + Daratumumab 16 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=45 participants at risk
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
Cohort 1: Nivolumab Monotherapy
n=74 participants at risk
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=119 participants at risk
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Ocular myasthenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Influenza like illness
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Pain
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Performance status decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Escherichia infection
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Peripheral swelling
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Pyrexia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Stenosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Sudden death
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Suprapubic pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Swelling
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Abscess
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Appendicitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Gait disturbance
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
General physical health deterioration
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Device related infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Encephalitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Encephalitis bacterial
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Incarcerated hernia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Wound infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Tracheal deviation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Implant site infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Lung abscess
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Meningitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Myelitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Peritonitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pneumococcal infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Respiratory tract infection
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Systemic infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
C-reactive protein increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Troponin I increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Troponin increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Necrotising myositis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
50.0%
5/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
9/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.0%
9/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
43.2%
19/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
13/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.1%
12/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Malignant spinal cord compression
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Product issues
Device dislocation
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Product issues
Thrombosis in device
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
Other adverse events
| Measure |
MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=10 participants at risk
MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
n=3 participants at risk
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
|
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
n=10 participants at risk
Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
|
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
n=30 participants at risk
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
|
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
n=50 participants at risk
Nivolumab 240 mg + BMS-986016 80 mg
|
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
n=44 participants at risk
Nivolumab FD + Daratumumab 16 mg/kg
|
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
n=45 participants at risk
Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
|
Cohort 1: Nivolumab Monotherapy
n=74 participants at risk
Nivolumab 3 mg/kg
|
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
n=119 participants at risk
Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Genital herpes
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Foreign body sensation in eyes
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Photophobia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal tenderness
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Aphthous ulcer
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Eructation
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Cholecystitis acute
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.4%
5/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.2%
12/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.4%
16/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Ascites
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
4/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.0%
8/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.2%
8/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
27.0%
20/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.7%
27/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
63.3%
19/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.0%
18/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.9%
18/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
44.4%
20/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
58.1%
43/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
61.3%
73/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.5%
7/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
10/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.0%
9/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
34.1%
15/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
37.8%
17/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
48.6%
36/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
32.8%
39/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
23.3%
7/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.0%
9/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.6%
6/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
31.1%
14/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.5%
30/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.1%
31/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Asthenia
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.0%
18/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
25.0%
11/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
31.1%
14/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
24.3%
18/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
31.9%
38/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Fatigue
|
50.0%
5/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
50.0%
5/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
43.3%
13/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.7%
10/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
15/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
52.7%
39/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.1%
43/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Feeling of body temperature change
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Restless legs syndrome
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Product issues
Device occlusion
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Hydronephrosis
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Renal pain
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
46.7%
14/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.0%
9/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.6%
6/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.2%
10/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
44.6%
33/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
34.5%
41/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.5%
7/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.4%
16/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
8/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
6/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.1%
18/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.0%
8/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.2%
10/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.2%
9/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.5%
22/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Serous retinopathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.0%
7/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
27.3%
12/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
31.1%
14/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
37.8%
28/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
31.1%
37/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
50.0%
15/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
General physical health deterioration
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Influenza like illness
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.4%
5/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.3%
17/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Mucosal inflammation
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.2%
9/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Oedema
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Oedema peripheral
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
13/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.9%
13/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Pain
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.0%
4/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
6/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
General disorders and administration site conditions
Pyrexia
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
50.0%
5/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
4/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.0%
18/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
29.5%
13/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
15/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.8%
25/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
43.7%
52/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.4%
5/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Eye infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.9%
14/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
21/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Rash pustular
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.1%
12/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
4/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
38.6%
17/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.7%
8/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
13/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.2%
24/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Amylase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.0%
7/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.0%
19/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
12/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
13/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
23.5%
28/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood albumin decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.9%
13/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.2%
10/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.9%
13/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
4/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.0%
4/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
23.0%
17/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
21.0%
25/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.5%
7/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.7%
5/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.4%
5/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.5%
7/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood calcium decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
50.0%
15/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.0%
7/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
9/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.8%
20/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood potassium increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood sodium decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Blood sodium increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Lipase increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.8%
8/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.9%
14/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.2%
24/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Lymphocyte count decreased
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.7%
8/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Troponin increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Weight decreased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.0%
4/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.8%
8/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Investigations
Weight increased
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.0%
4/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.2%
9/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
70.0%
7/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
10/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
28.0%
14/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
25.0%
11/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
24.4%
11/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.3%
15/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.1%
31/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.2%
9/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.8%
14/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.5%
7/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.3%
15/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.8%
8/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
9/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Psychiatric disorders
Insomnia
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
9/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
21.8%
26/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.7%
8/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
23.3%
7/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
8/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
5/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
7.6%
9/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
15/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
35.6%
16/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
32.4%
24/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.1%
31/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.8%
8/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
21.6%
16/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.3%
36/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.5%
2/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.2%
5/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.1%
6/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.8%
8/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.9%
14/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.3%
17/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
23.3%
7/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.0%
8/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.7%
10/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
22.2%
10/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.5%
27/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
36.1%
43/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.1%
4/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
5/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
66.7%
2/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
40.0%
4/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
5/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.5%
9/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.6%
7/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.2%
12/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
16.8%
20/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.3%
4/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.0%
4/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
15.1%
18/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
2/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
11.1%
5/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.0%
3/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
3/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
13.5%
10/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
17.6%
21/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.4%
4/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
9.2%
11/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.7%
2/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
30.0%
9/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
18.0%
9/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
44.4%
20/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
29.7%
22/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.6%
40/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
33.3%
1/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.7%
8/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
12.0%
6/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.8%
3/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
26.7%
12/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
21.6%
16/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
21.8%
26/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
6/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
14.9%
11/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
20.0%
2/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.4%
2/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.5%
3/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.7%
2/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.0%
2/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.9%
7/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
4.1%
3/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
5.0%
6/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.9%
4/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.4%
4/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
10.0%
1/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.0%
1/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.3%
1/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
2.2%
1/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
1.4%
1/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
8.4%
10/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/3 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/10 • From Day 1 and up to approximately 127 months.
All treated participants
|
3.3%
1/30 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/50 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/44 • From Day 1 and up to approximately 127 months.
All treated participants
|
6.7%
3/45 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.00%
0/74 • From Day 1 and up to approximately 127 months.
All treated participants
|
0.84%
1/119 • From Day 1 and up to approximately 127 months.
All treated participants
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER