Trial Outcomes & Findings for An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (NCT NCT02477826)
NCT ID: NCT02477826
Last Updated: 2025-10-30
Results Overview
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2747 participants
Primary outcome timeframe
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Results posted on
2025-10-30
Participant Flow
Participant milestones
| Measure |
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Treatment
STARTED
|
396
|
396
|
397
|
187
|
177
|
186
|
377
|
378
|
126
|
127
|
|
Pre-Treatment
COMPLETED
|
391
|
391
|
387
|
185
|
172
|
183
|
375
|
371
|
126
|
123
|
|
Pre-Treatment
NOT COMPLETED
|
5
|
5
|
10
|
2
|
5
|
3
|
2
|
7
|
0
|
4
|
|
Treatment Period
STARTED
|
391
|
391
|
387
|
185
|
172
|
183
|
375
|
371
|
126
|
123
|
|
Treatment Period
COMPLETED
|
45
|
37
|
94
|
14
|
20
|
32
|
40
|
83
|
0
|
37
|
|
Treatment Period
NOT COMPLETED
|
346
|
354
|
293
|
171
|
152
|
151
|
335
|
288
|
126
|
86
|
Reasons for withdrawal
| Measure |
Part 1-Arm B: Nivo + Ipi
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Treatment
Adverse events unrelated to study drug
|
0
|
1
|
2
|
1
|
0
|
0
|
1
|
5
|
0
|
0
|
|
Pre-Treatment
Other reasons
|
4
|
1
|
4
|
1
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Pre-Treatment
Subject no longer meets study criteria
|
1
|
2
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Pre-Treatment
Subject withdrew consent
|
0
|
0
|
3
|
0
|
0
|
1
|
0
|
1
|
0
|
3
|
|
Pre-Treatment
Subject request to discontinue study treatment
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Pre-Treatment
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period
Not reported
|
8
|
6
|
4
|
4
|
2
|
1
|
14
|
8
|
5
|
2
|
|
Treatment Period
Other reasons
|
5
|
6
|
12
|
7
|
5
|
1
|
8
|
8
|
21
|
1
|
|
Treatment Period
Administrative reason by sponsor
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Participant meet no longer study criteria
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Treatment Period
Poor/Non Compliance
|
1
|
0
|
2
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
|
Treatment Period
Maximum Clinical Benefit
|
3
|
3
|
1
|
1
|
3
|
0
|
3
|
2
|
2
|
2
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
|
Treatment Period
Participant withdrew Consent
|
5
|
5
|
3
|
3
|
1
|
3
|
3
|
3
|
2
|
3
|
|
Treatment Period
Participant request to discontinue treatment
|
5
|
3
|
15
|
5
|
3
|
6
|
13
|
15
|
4
|
18
|
|
Treatment Period
Adverse event unrelated to study drug
|
23
|
29
|
22
|
18
|
11
|
15
|
25
|
19
|
4
|
2
|
|
Treatment Period
Death
|
4
|
7
|
0
|
0
|
1
|
2
|
6
|
5
|
9
|
0
|
|
Treatment Period
Study Drug Toxicity
|
79
|
51
|
31
|
39
|
12
|
25
|
52
|
30
|
20
|
9
|
|
Treatment Period
Disease progression
|
212
|
240
|
202
|
93
|
113
|
96
|
208
|
195
|
59
|
46
|
|
Treatment Period
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Part 1-Arm B: Nivo + Ipi
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=397 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=187 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=177 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=186 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=377 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=378 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=127 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Total
n=2747 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65
|
199 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
214 Participants
n=8 Participants
|
196 Participants
n=24 Participants
|
82 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
1488 Participants
n=42 Participants
|
|
Age, Customized
=>65
|
197 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
88 Participants
n=8 Participants
|
163 Participants
n=8 Participants
|
182 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
43 Participants
n=42 Participants
|
1259 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
113 Participants
n=8 Participants
|
115 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
825 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=5 Participants
|
272 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
125 Participants
n=8 Participants
|
264 Participants
n=8 Participants
|
263 Participants
n=24 Participants
|
108 Participants
n=42 Participants
|
107 Participants
n=42 Participants
|
1922 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
299 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
133 Participants
n=8 Participants
|
272 Participants
n=8 Participants
|
266 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1871 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
84 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
93 Participants
n=8 Participants
|
94 Participants
n=24 Participants
|
126 Participants
n=42 Participants
|
127 Participants
n=42 Participants
|
797 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)Population: All randomized participants
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part 1-Arm B: Nivo + Ipi
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=397 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=187 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=177 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=186 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=377 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=378 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=127 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival Per BICR
|
5.06 months
Interval 4.07 to 6.31
|
4.17 months
Interval 3.22 to 5.32
|
5.55 months
Interval 4.63 to 5.82
|
4.90 months
Interval 3.15 to 6.28
|
5.55 months
Interval 4.63 to 6.9
|
4.70 months
Interval 4.21 to 5.59
|
8.34 months
Interval 7.1 to 9.59
|
5.52 months
Interval 4.47 to 5.85
|
5.78 months
Interval 4.14 to 8.34
|
5.49 months
Interval 4.37 to 6.77
|
PRIMARY outcome
Timeframe: From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)Population: All randomized participants
OS for all randomized participants is the time between randomization date and the date of death from any cause.
Outcome measures
| Measure |
Part 1-Arm B: Nivo + Ipi
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=397 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=187 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=177 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=186 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=377 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=378 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=127 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
17.12 months
Interval 14.95 to 20.17
|
15.70 months
Interval 13.27 to 18.14
|
14.88 months
Interval 12.71 to 16.72
|
17.45 months
Interval 13.21 to 22.05
|
15.21 months
Interval 12.29 to 19.78
|
12.19 months
Interval 9.17 to 14.32
|
18.27 months
Interval 15.84 to 21.65
|
14.72 months
Interval 12.42 to 16.79
|
20.99 months
Interval 16.95 to 25.17
|
15.11 months
Interval 13.17 to 18.89
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)Population: All randomized participants
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 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 |
Part 1-Arm B: Nivo + Ipi
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=397 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=187 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=177 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=186 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=377 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=378 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=127 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per BICR
|
36.4 percentage of participants
Interval 31.6 to 41.3
|
27.5 percentage of participants
Interval 23.2 to 32.2
|
29.7 percentage of participants
Interval 25.3 to 34.5
|
26.2 percentage of participants
Interval 20.1 to 33.1
|
37.9 percentage of participants
Interval 30.7 to 45.4
|
23.1 percentage of participants
Interval 17.3 to 29.8
|
52.3 percentage of participants
Interval 47.1 to 57.4
|
29.9 percentage of participants
Interval 25.3 to 34.8
|
38.1 percentage of participants
Interval 29.6 to 47.2
|
30.7 percentage of participants
Interval 22.8 to 39.5
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Outcome measures
| Measure |
Part 1-Arm B: Nivo + Ipi
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=396 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=397 Participants
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=187 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=177 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=186 Participants
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=377 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=378 Participants
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=127 Participants
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
|
31.3 percentage of participants
Interval 26.8 to 36.1
|
35.4 percentage of participants
Interval 30.6 to 40.3
|
25.7 percentage of participants
Interval 21.5 to 30.3
|
33.2 percentage of participants
Interval 26.5 to 40.4
|
28.8 percentage of participants
Interval 22.3 to 36.1
|
37.6 percentage of participants
Interval 30.7 to 45.0
|
30.0 percentage of participants
Interval 25.4 to 34.9
|
24.3 percentage of participants
Interval 20.1 to 29.0
|
23.0 percentage of participants
Interval 16.0 to 31.4
|
26.0 percentage of participants
Interval 18.6 to 34.5
|
Adverse Events
Part 1-Arm B: Nivo + Ipi
Serious events: 275 serious events
Other events: 366 other events
Deaths: 316 deaths
Part 1-Arm A: Nivolumab
Serious events: 239 serious events
Other events: 356 other events
Deaths: 333 deaths
Part 1-Arm C: Chemotherapy
Serious events: 213 serious events
Other events: 361 other events
Deaths: 339 deaths
Part 1-Arm D: Nivo + Ipi
Serious events: 128 serious events
Other events: 172 other events
Deaths: 159 deaths
Part 1-Arm G: Nivo + Chemo
Serious events: 112 serious events
Other events: 167 other events
Deaths: 157 deaths
Part 1-Arm F: Chemotherapy
Serious events: 91 serious events
Other events: 165 other events
Deaths: 174 deaths
Part 2 - Arm H: Nivolumab + Chemotherapy
Serious events: 240 serious events
Other events: 357 other events
Deaths: 314 deaths
Part 2 - Arm I: Chemotherapy
Serious events: 180 serious events
Other events: 345 other events
Deaths: 335 deaths
Part 3 -Arm J: Nivolumab + Ipilimumab
Serious events: 78 serious events
Other events: 124 other events
Deaths: 95 deaths
Part 3 - Arm K: Chemotherapy
Serious events: 60 serious events
Other events: 121 other events
Deaths: 94 deaths
Serious adverse events
| Measure |
Part 1-Arm B: Nivo + Ipi
n=391 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=391 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=387 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=185 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=172 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=183 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=375 participants at risk
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=371 participants at risk
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 participants at risk
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=123 participants at risk
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Respiratory tract infection
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Sepsis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Septic shock
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Skin infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Soft tissue infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Systemic candida
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Tooth infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Urinary tract infection
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Urosepsis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Viral infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Viral pericarditis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Wound infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Femoral nerve injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Alanine aminotransferase increased
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Amylase increased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood alkaline phosphatase increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood calcium decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood creatinine increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood glucose increased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood potassium decreased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Electrocardiogram QT prolonged
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Eosinophil count increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
General physical condition abnormal
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Hepatic enzyme increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Lipase increased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Liver function test abnormal
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Liver function test increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Pancreatic enzymes increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Platelet count decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Transaminases increased
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Troponin increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Weight decreased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
White blood cell count decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female reproductive neoplasm
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haematological malignancy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary cancer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.1%
98/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.1%
102/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.5%
87/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.1%
39/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
27.9%
48/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.4%
41/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.6%
81/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.0%
78/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.3%
18/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Atonic seizures
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Brain oedema
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebral ischaemia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Encephalopathy
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Epilepsy
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Headache
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
8/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.1%
8/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Lethargy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Neuralgia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Presyncope
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Seizure
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Somnolence
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Syncope
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Vertebrobasilar artery dissection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Vocal cord paralysis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Product Issues
Device dislocation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Product Issues
Device physical property issue
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Confusional state
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Delirium
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Depression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Nephrogenic diabetes insipidus
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Renal failure
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Renal vascular thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
5/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
4/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.1%
20/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
5/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.7%
14/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
11/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
6/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Autoimmune dermatitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Arteritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Embolism
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Haematoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypertension
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypotension
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Infarction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Shock
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Superior vena cava occlusion
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Superior vena cava syndrome
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Vasculitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Vena cava thrombosis
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Venous thrombosis limb
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Death
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Gastroenteritis viral
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.7%
14/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
7/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Splenic thrombosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Acute myocardial infarction
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Atrial flutter
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac failure
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac failure acute
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac failure congestive
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiac tamponade
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Myocarditis
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Palpitations
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Pericardial effusion
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Pericardial effusion malignant
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Cardiac disorders
Torsade de pointes
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Adrenal insufficiency
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hyperthyroidism
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hypophysitis
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hypopituitarism
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hypothyroidism
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Eye disorders
Cataract
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Eye disorders
Diplopia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Colitis
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Constipation
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
4/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Dysphagia
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Enterocolitis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gastritis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Immune-mediated gastritis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Melaena
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Odynophagia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Oesophagitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Adverse drug reaction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Asthenia
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Chest discomfort
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Chest pain
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Chills
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Complication associated with device
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Face oedema
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Fatigue
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
General physical health deterioration
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Generalised oedema
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Hyperthermia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Hypothermia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Inflammation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Influenza like illness
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Malaise
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Mucosal inflammation
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Pain
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Performance status decreased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Pyrexia
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.8%
6/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Sudden death
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
4/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Swelling
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatitis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Contrast media allergy
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Drug hypersensitivity
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Abscess
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Abscess limb
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Anal abscess
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Appendicitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Aspergillus infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bronchitis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Cellulitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Dermo-hypodermitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Empyema
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Encephalitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Enterocolitis infectious
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Erysipelas
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Febrile infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Groin infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Herpes zoster
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Infectious pleural effusion
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Influenza
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Injection site infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Large intestine infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Lower respiratory tract infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Lung abscess
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Meningitis viral
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Metapneumovirus infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Myelitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Osteomyelitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Peritonitis
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pleural infection
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia
|
10.2%
40/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.4%
29/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
31/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.7%
18/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
15/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.1%
34/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.8%
29/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
11/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia aspiration
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia bacterial
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia klebsiella
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia viral
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pseudomembranous colitis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pulmonary sepsis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
Other adverse events
| Measure |
Part 1-Arm B: Nivo + Ipi
n=391 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm A: Nivolumab
n=391 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm C: Chemotherapy
n=387 participants at risk
Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm D: Nivo + Ipi
n=185 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 1-Arm G: Nivo + Chemo
n=172 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 1-Arm F: Chemotherapy
n=183 participants at risk
Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm H: Nivolumab + Chemotherapy
n=375 participants at risk
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 2 - Arm I: Chemotherapy
n=371 participants at risk
Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
Part 3 -Arm J: Nivolumab + Ipilimumab
n=126 participants at risk
Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity.
|
Part 3 - Arm K: Chemotherapy
n=123 participants at risk
Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood glucose increased
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
7/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
11/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
47/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.5%
37/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
27/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.3%
16/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
12/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.8%
48/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
36.5%
46/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.0%
32/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.1%
14/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood alkaline phosphatase increased
|
5.4%
21/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
13/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
7/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.1%
23/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.3%
18/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood bilirubin increased
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.3%
23/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
10/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Blood creatinine increased
|
5.9%
23/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
15/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
13/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.5%
18/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.5%
10/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.9%
41/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.8%
29/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.3%
13/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Anaemia
|
12.0%
47/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.0%
51/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
41.1%
159/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
25/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
46.5%
80/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
41.5%
76/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
46.4%
174/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
40.7%
151/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
50.0%
63/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
75.6%
93/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.1%
9/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
19/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
15/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
5/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.3%
25/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.1%
70/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.2%
45/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.2%
37/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.6%
66/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.6%
58/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.0%
16/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.1%
39/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.9%
17/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
14/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.8%
48/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.4%
31/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.4%
14/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hyperthyroidism
|
8.4%
33/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.6%
18/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.3%
19/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
11/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.9%
20/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Endocrine disorders
Hypothyroidism
|
15.6%
61/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
22/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.8%
33/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.4%
27/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Eye disorders
Lacrimation increased
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.7%
18/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.3%
20/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
30/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
15/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
18/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
22/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
5/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.9%
22/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
13/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Constipation
|
19.9%
78/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.9%
70/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.9%
104/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.5%
36/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
36.6%
63/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
29.0%
53/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.4%
84/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.4%
83/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.9%
20/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.3%
25/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Diarrhoea
|
26.1%
102/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.5%
88/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.1%
66/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.8%
44/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.1%
38/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.0%
33/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.1%
79/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.9%
48/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.6%
26/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
17/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
11/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
15/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
13/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
8/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.53%
2/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Nausea
|
23.8%
93/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.7%
81/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
45.0%
174/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.2%
41/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
45.9%
79/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
40.4%
74/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
33.6%
126/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
35.8%
133/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
17/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
24.4%
30/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
25/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.2%
28/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.3%
16/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.0%
11/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.5%
17/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
52/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.5%
41/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.9%
73/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
27/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.2%
33/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.6%
34/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.7%
55/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.1%
56/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.9%
20/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.3%
25/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Asthenia
|
23.8%
93/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.9%
78/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.1%
66/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.6%
40/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.3%
35/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.0%
42/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.7%
70/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.0%
52/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
17/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Chest discomfort
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.1%
14/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
7/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Chest pain
|
4.9%
19/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.6%
18/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.4%
13/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
6/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
12/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
14/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
5/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Fatigue
|
27.4%
107/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
22.5%
88/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.1%
101/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
20.5%
38/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
31.4%
54/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
27.3%
50/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.2%
87/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.6%
80/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.3%
18/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.7%
23/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Malaise
|
2.8%
11/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
17/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
13/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.0%
11/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.3%
20/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
24/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.5%
12/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.6%
13/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Mucosal inflammation
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
13/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.1%
13/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
19/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Non-cardiac chest pain
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
20/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.2%
17/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
12/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.8%
18/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
15/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.8%
12/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Oedema peripheral
|
12.5%
49/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
26/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.6%
37/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.7%
18/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.7%
27/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.6%
23/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.7%
40/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.2%
38/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.9%
10/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Pain
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
6/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.9%
10/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
General disorders
Pyrexia
|
18.9%
74/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
57/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.8%
38/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.3%
32/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.2%
33/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.5%
32/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.4%
54/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.2%
38/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
31.7%
40/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.8%
17/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
2/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Bronchitis
|
4.3%
17/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.8%
18/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
27/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.9%
23/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
22/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
15/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.7%
14/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Pneumonia
|
5.4%
21/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
20/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
17/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
12/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.1%
23/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
27/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.7%
16/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
14/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
17/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
14/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
14/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.7%
16/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.1%
8/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Alanine aminotransferase increased
|
11.0%
43/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.2%
40/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
27/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.8%
31/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.8%
22/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.2%
15/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.8%
48/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.8%
29/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
33.3%
42/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
29.3%
36/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Amylase increased
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
22/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.7%
18/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.9%
17/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.8%
33/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.6%
17/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.0%
24/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.2%
2/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.5%
17/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.3%
23/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.0%
16/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Lipase increased
|
7.9%
31/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.9%
27/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.6%
14/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
25/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
12/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.2%
27/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
15/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
6/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Lymphocyte count decreased
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.0%
4/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.7%
8/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.80%
3/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.9%
10/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Neutrophil count decreased
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.9%
50/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.0%
31/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.9%
20/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.9%
52/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
54/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.7%
16/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
43.9%
54/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Neutrophil count increased
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Platelet count decreased
|
1.5%
6/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
31/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.8%
22/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.7%
25/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.1%
38/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
30/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.5%
22/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
39.8%
49/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Weight decreased
|
9.5%
37/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
20/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
22/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.2%
17/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
14/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.5%
32/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.4%
31/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
34.9%
44/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.4%
19/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
Weight increased
|
2.0%
8/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.0%
8/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.7%
3/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
10/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Investigations
White blood cell count decreased
|
2.0%
8/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
19/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.54%
1/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.9%
17/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.9%
41/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.5%
39/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.5%
22/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
48.0%
59/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.2%
130/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
24.8%
97/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
28.2%
109/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
33.0%
61/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
35.5%
61/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
28.4%
52/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
28.0%
105/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.7%
88/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
31.7%
40/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
27.6%
34/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
24/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.6%
14/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
6/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
29/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
20/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.3%
18/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.6%
13/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
11/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.0%
11/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.8%
6/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
5/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.52%
2/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.26%
1/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.9%
20/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
25/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.6%
14/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.7%
8/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
15/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
32.5%
41/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.3%
20/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
7/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
6/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.1%
14/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
17/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.3%
9/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
27/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
13/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
13/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.2%
27/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
21/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.0%
24/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
10/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.7%
15/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
12/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.9%
22/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.9%
10/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
6/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
39/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
17/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
20/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
14/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
11/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
37.3%
47/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
18/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.6%
14/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
7/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
8/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.58%
1/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
3/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
15/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.4%
14/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
72/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.9%
62/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
19/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.1%
26/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.3%
28/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.7%
40/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.8%
40/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.5%
17/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
7/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
42/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.2%
36/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
31/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.1%
28/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.4%
23/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.1%
13/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.1%
38/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.8%
29/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.9%
10/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
23/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
22/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
30/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
21/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
17/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.1%
24/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
7/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
14/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.7%
25/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
21/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
4/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.6%
18/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Dizziness
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
21/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
27/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.6%
16/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.5%
18/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.5%
21/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.3%
31/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
18/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.7%
16/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.1%
10/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Dysgeusia
|
3.6%
14/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
25/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
11/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.5%
17/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
14/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Headache
|
13.8%
54/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.2%
40/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
31/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
13/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.0%
19/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.1%
34/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
24/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.5%
12/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
8/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.26%
1/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.3%
5/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.8%
11/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
2/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
4/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.9%
26/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
12/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Nervous system disorders
Paraesthesia
|
3.6%
14/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.51%
2/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
19/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Anxiety
|
5.6%
22/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
19/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
7/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
13/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Psychiatric disorders
Insomnia
|
11.0%
43/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.2%
32/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.8%
30/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.4%
23/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.5%
25/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.0%
11/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.3%
31/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.2%
23/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
17.5%
22/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.9%
11/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.2%
75/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.0%
82/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.6%
45/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.8%
31/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
26.2%
45/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.8%
27/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
18.4%
69/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
44/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.8%
30/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.6%
18/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.1%
98/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.8%
93/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.8%
61/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
25.4%
47/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
23.3%
40/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.3%
39/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
19.7%
74/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.8%
55/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.1%
19/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.0%
16/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.77%
3/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.4%
13/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
6/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.9%
11/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.7%
34/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.6%
26/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.7%
22/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
9.2%
17/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.0%
11/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.1%
19/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.4%
20/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
24.6%
31/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.8%
17/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.8%
7/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.6%
10/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
20/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
14/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
13/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.5%
13/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
6/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
22/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.9%
23/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.78%
3/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
7/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.55%
1/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
16/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.27%
1/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
7/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.00%
0/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.2%
28/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.7%
30/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.9%
15/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.5%
12/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
11/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
24/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
15/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.9%
15/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.4%
14/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
8/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.8%
34/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
3/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
12/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.5%
10/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.0%
45/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.1%
45/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
5/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
37/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.6%
14/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.1%
12/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.9%
9/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.4%
11/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.9%
7/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.79%
1/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.5%
92/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
11.3%
44/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
17/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.7%
29/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
13.4%
23/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
5/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
10.1%
38/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.0%
11/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
21.4%
27/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.1%
5/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.8%
93/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
14.1%
55/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.0%
31/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.8%
31/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
16.9%
29/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.1%
13/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
15.7%
59/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
8.6%
32/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
25.4%
32/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
12.2%
15/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.2%
28/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.8%
7/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.6%
14/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.2%
9/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
4/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.7%
10/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.1%
4/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
5/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
1.6%
2/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypertension
|
5.4%
21/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.8%
15/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.4%
13/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.3%
8/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
7.0%
12/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.6%
21/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
8/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
6.3%
8/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
3/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
|
Vascular disorders
Hypotension
|
4.1%
16/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.3%
13/391 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.3%
9/387 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
3.2%
6/185 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
5.8%
10/172 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.4%
8/183 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.4%
9/375 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
2.2%
8/371 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
4.0%
5/126 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized participants
|
0.81%
1/123 • Serious and non-serious adverse events were collected from first dose (Day 1) and 30 days after last dose of study therapy (up to approximately 105 months) and all cause mortality was collected from Day 1 and up to 481 weeks.
Randomized 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