Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (NCT NCT02819635)
NCT ID: NCT02819635
Last Updated: 2022-06-30
Results Overview
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1302 participants
Primary outcome timeframe
At Week 8
Results posted on
2022-06-30
Participant Flow
Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all participants who received at least one dose of study drug in Substudy 3)
Participant milestones
| Measure |
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS2: Placebo/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS3: M14-675 Clinical Responders
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
|
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
|
SS3: UPA 7.5 mg
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
|
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
|
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy 1 and Substudy 2, Part 1
STARTED
|
46
|
47
|
49
|
117
|
123
|
155
|
319
|
446
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
COMPLETED
|
41
|
45
|
45
|
105
|
113
|
135
|
306
|
446
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
NOT COMPLETED
|
5
|
2
|
4
|
12
|
10
|
20
|
13
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
85
|
59
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
74
|
47
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
11
|
12
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 3
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
386
|
20
|
324
|
316
|
|
Substudy 3
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
140
|
11
|
218
|
248
|
|
Substudy 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
246
|
9
|
106
|
68
|
Reasons for withdrawal
| Measure |
SS1: Placebo
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS2: Placebo/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS3: M14-675 Clinical Responders
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
|
SS3: Placebo
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
|
SS3: UPA 7.5 mg
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
|
SS3: UPA 15 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
|
SS3: UPA 30 mg
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy 1 and Substudy 2, Part 1
Adverse Event
|
3
|
1
|
3
|
5
|
4
|
9
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
Withdrew consent
|
0
|
0
|
0
|
0
|
1
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
COVID-19 Logistical Restrictions
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 1 and Substudy 2, Part 1
Other, not specified
|
2
|
1
|
1
|
7
|
5
|
7
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
Withdrew consent
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
COVID-19 Logistical Restrictions
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 2, Part 2
Other, not specified
|
0
|
0
|
0
|
0
|
0
|
4
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Substudy 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
32
|
3
|
12
|
18
|
|
Substudy 3
Withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
1
|
4
|
9
|
|
Substudy 3
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Substudy 3
COVID-19 Logistical Restrictions
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Substudy 3
Other, not specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
202
|
5
|
89
|
39
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=117 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=123 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS2: Placebo/Upadacitinib 45 mg
n=155 Participants
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
n=319 Participants
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS3: M14-675 Clinical Responders
n=446 Participants
Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \[QD\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.
|
Total
n=1302 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 13.29 • n=46 Participants
|
41.7 years
STANDARD_DEVIATION 14.58 • n=47 Participants
|
46.0 years
STANDARD_DEVIATION 13.58 • n=49 Participants
|
42.9 years
STANDARD_DEVIATION 14.44 • n=117 Participants
|
41.6 years
STANDARD_DEVIATION 14.19 • n=123 Participants
|
44.3 years
STANDARD_DEVIATION 14.64 • n=155 Participants
|
43.6 years
STANDARD_DEVIATION 14.04 • n=319 Participants
|
42.1 years
STANDARD_DEVIATION 14.42 • n=446 Participants
|
42.9 years
STANDARD_DEVIATION 14.27 • n=1302 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=46 Participants
|
24 Participants
n=47 Participants
|
19 Participants
n=49 Participants
|
47 Participants
n=117 Participants
|
44 Participants
n=123 Participants
|
58 Participants
n=155 Participants
|
121 Participants
n=319 Participants
|
170 Participants
n=446 Participants
|
500 Participants
n=1302 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=46 Participants
|
23 Participants
n=47 Participants
|
30 Participants
n=49 Participants
|
70 Participants
n=117 Participants
|
79 Participants
n=123 Participants
|
97 Participants
n=155 Participants
|
198 Participants
n=319 Participants
|
276 Participants
n=446 Participants
|
802 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=46 Participants
|
36 Participants
n=47 Participants
|
38 Participants
n=49 Participants
|
88 Participants
n=117 Participants
|
90 Participants
n=123 Participants
|
101 Participants
n=155 Participants
|
206 Participants
n=319 Participants
|
302 Participants
n=446 Participants
|
898 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=46 Participants
|
3 Participants
n=47 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=117 Participants
|
2 Participants
n=123 Participants
|
4 Participants
n=155 Participants
|
12 Participants
n=319 Participants
|
15 Participants
n=446 Participants
|
40 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=46 Participants
|
7 Participants
n=47 Participants
|
10 Participants
n=49 Participants
|
23 Participants
n=117 Participants
|
28 Participants
n=123 Participants
|
46 Participants
n=155 Participants
|
95 Participants
n=319 Participants
|
124 Participants
n=446 Participants
|
341 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=46 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=117 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=155 Participants
|
0 Participants
n=319 Participants
|
1 Participants
n=446 Participants
|
4 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants
|
0 Participants
n=47 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=155 Participants
|
1 Participants
n=319 Participants
|
1 Participants
n=446 Participants
|
2 Participants
n=1302 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=46 Participants
|
1 Participants
n=47 Participants
|
0 Participants
n=49 Participants
|
2 Participants
n=117 Participants
|
3 Participants
n=123 Participants
|
2 Participants
n=155 Participants
|
5 Participants
n=319 Participants
|
3 Participants
n=446 Participants
|
17 Participants
n=1302 Participants
|
|
Average Stool Frequency Subscore
|
2.56 units on a scale
STANDARD_DEVIATION 0.667 • n=46 Participants • Participants with available data
|
2.62 units on a scale
STANDARD_DEVIATION 0.600 • n=47 Participants • Participants with available data
|
2.68 units on a scale
STANDARD_DEVIATION 0.565 • n=49 Participants • Participants with available data
|
2.61 units on a scale
STANDARD_DEVIATION 0.613 • n=117 Participants • Participants with available data
|
2.58 units on a scale
STANDARD_DEVIATION 0.648 • n=122 Participants • Participants with available data
|
2.52 units on a scale
STANDARD_DEVIATION 0.668 • n=155 Participants • Participants with available data
|
2.60 units on a scale
STANDARD_DEVIATION 0.624 • n=318 Participants • Participants with available data
|
2.55 units on a scale
STANDARD_DEVIATION 0.623 • n=445 Participants • Participants with available data
|
2.58 units on a scale
STANDARD_DEVIATION 0.628 • n=1299 Participants • Participants with available data
|
|
Average Rectal Bleeding Subscore
|
1.66 units on a scale
STANDARD_DEVIATION 1.034 • n=46 Participants • Participants with available data
|
1.61 units on a scale
STANDARD_DEVIATION 1.027 • n=47 Participants • Participants with available data
|
1.55 units on a scale
STANDARD_DEVIATION 0.915 • n=49 Participants • Participants with available data
|
1.51 units on a scale
STANDARD_DEVIATION 0.975 • n=117 Participants • Participants with available data
|
1.49 units on a scale
STANDARD_DEVIATION 0.960 • n=122 Participants • Participants with available data
|
1.76 units on a scale
STANDARD_DEVIATION 0.994 • n=155 Participants • Participants with available data
|
1.71 units on a scale
STANDARD_DEVIATION 1.046 • n=318 Participants • Participants with available data
|
1.77 units on a scale
STANDARD_DEVIATION 0.990 • n=445 Participants • Participants with available data
|
1.68 units on a scale
STANDARD_DEVIATION 1.003 • n=1299 Participants • Participants with available data
|
|
Average Endoscopy Subscore
|
2.8 units on a scale
STANDARD_DEVIATION 0.43 • n=46 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.40 • n=47 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 0.39 • n=49 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.47 • n=117 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.48 • n=123 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.47 • n=155 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.46 • n=319 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.47 • n=446 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 0.46 • n=1302 Participants
|
|
Previous Biologic Use
Yes
|
35 Participants
n=46 Participants • Participants with available data
|
36 Participants
n=47 Participants • Participants with available data
|
38 Participants
n=49 Participants • Participants with available data
|
87 Participants
n=117 Participants • Participants with available data
|
92 Participants
n=123 Participants • Participants with available data
|
—
|
—
|
—
|
288 Participants
n=382 Participants • Participants with available data
|
|
Previous Biologic Use
No
|
11 Participants
n=46 Participants • Participants with available data
|
11 Participants
n=47 Participants • Participants with available data
|
11 Participants
n=49 Participants • Participants with available data
|
30 Participants
n=117 Participants • Participants with available data
|
31 Participants
n=123 Participants • Participants with available data
|
—
|
—
|
—
|
94 Participants
n=382 Participants • Participants with available data
|
|
Biologic-inadequate Responder (Bio-IR) Status
Bio-IR
|
—
|
—
|
—
|
—
|
—
|
79 Participants
n=155 Participants • Participants with available data
|
168 Participants
n=319 Participants • Participants with available data
|
221 Participants
n=446 Participants • Participants with available data
|
468 Participants
n=920 Participants • Participants with available data
|
|
Biologic-inadequate Responder (Bio-IR) Status
Non-Bio-IR
|
—
|
—
|
—
|
—
|
—
|
76 Participants
n=155 Participants • Participants with available data
|
151 Participants
n=319 Participants • Participants with available data
|
225 Participants
n=446 Participants • Participants with available data
|
452 Participants
n=920 Participants • Participants with available data
|
|
Baseline Corticosteroid Use
Yes
|
26 Participants
n=46 Participants
|
24 Participants
n=47 Participants
|
27 Participants
n=49 Participants
|
51 Participants
n=117 Participants
|
53 Participants
n=123 Participants
|
62 Participants
n=155 Participants
|
124 Participants
n=319 Participants
|
173 Participants
n=446 Participants
|
540 Participants
n=1302 Participants
|
|
Baseline Corticosteroid Use
No
|
20 Participants
n=46 Participants
|
23 Participants
n=47 Participants
|
22 Participants
n=49 Participants
|
66 Participants
n=117 Participants
|
70 Participants
n=123 Participants
|
93 Participants
n=155 Participants
|
195 Participants
n=319 Participants
|
273 Participants
n=446 Participants
|
762 Participants
n=1302 Participants
|
PRIMARY outcome
Timeframe: At Week 8Population: SS1 main population (ITT1A): those randomized to ≥1 dose of study drug during the initial part of SS1. Non-responder imputation (NRI) was used to impute missing values.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
|
0 percentage of participants
|
8.5 percentage of participants
|
14.3 percentage of participants
|
13.5 percentage of participants
|
21.4 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 8Population: SS2, Part 1 population (ITT1): all randomized participants in the 8-week double-blind induction period who received ≥1 dose of study drug. NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used for SS2, with participants analyzed according to treatment groups to which they were randomized.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration) The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
|
4.8 percentage of participants
|
26.1 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52
|
12.1 percentage of participants
Interval 6.9 to 17.4
|
42.3 percentage of participants
Interval 34.3 to 50.3
|
51.7 percentage of participants
Interval 43.6 to 59.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8
|
2.2 percentage of participants
|
14.9 percentage of participants
|
30.6 percentage of participants
|
26.9 percentage of participants
|
35.7 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8
|
0 percentage of participants
|
10.6 percentage of participants
|
10.2 percentage of participants
|
11.5 percentage of participants
|
19.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
|
13.0 percentage of participants
|
29.8 percentage of participants
|
49.0 percentage of participants
|
46.2 percentage of participants
|
55.4 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 2Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
|
17.4 percentage of participants
|
23.4 percentage of participants
|
34.7 percentage of participants
|
36.5 percentage of participants
|
55.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Last observation carried forward (LOCF) was used for missing data.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Outcome measures
| Measure |
SS1: Placebo
n=41 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=43 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=44 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=44 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=48 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Change in Full Mayo Score From Baseline to Week 8
|
-0.741 units on a scale
Standard Deviation 2.3302
|
-2.870 units on a scale
Standard Deviation 2.9685
|
-3.589 units on a scale
Standard Deviation 2.4984
|
-4.211 units on a scale
Standard Deviation 3.0886
|
-4.606 units on a scale
Standard Deviation 2.8976
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8
|
0 percentage of participants
|
6.4 percentage of participants
|
4.1 percentage of participants
|
9.6 percentage of participants
|
17.9 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.
Outcome measures
| Measure |
SS1: Placebo
n=46 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=52 Participants
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=56 Participants
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
|
6.5 percentage of participants
|
31.9 percentage of participants
|
51.0 percentage of participants
|
44.2 percentage of participants
|
48.2 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8
|
7.4 percentage of participants
Interval 3.2 to 11.5
|
36.3 percentage of participants
Interval 31.0 to 41.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8
|
1.3 percentage of participants
Interval 0.0 to 3.1
|
13.7 percentage of participants
Interval 9.9 to 17.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8
|
27.3 percentage of participants
Interval 20.2 to 34.3
|
72.6 percentage of participants
Interval 67.7 to 77.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 2Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2
|
27.3 percentage of participants
Interval 20.2 to 34.3
|
60.1 percentage of participants
Interval 54.7 to 65.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
|
6.6 percentage of participants
Interval 2.6 to 10.5
|
30.1 percentage of participants
Interval 25.0 to 35.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Bowel urgency was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8
|
21.4 percentage of participants
Interval 14.9 to 27.9
|
48.4 percentage of participants
Interval 42.9 to 53.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Abdominal pain was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8
|
23.4 percentage of participants
Interval 16.7 to 30.1
|
46.6 percentage of participants
Interval 41.1 to 52.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8
|
22.5 percentage of participants
Interval 15.9 to 29.1
|
55.0 percentage of participants
Interval 49.5 to 60.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8Population: The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
SS1: Placebo
n=125 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=292 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
|
21.7 units on a scale
Interval 16.03 to 27.28
|
55.3 units on a scale
Interval 51.54 to 59.15
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 8Population: The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
SS1: Placebo
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=319 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8
|
1.3 percentage of participants
Interval 0.0 to 3.1
|
10.7 percentage of participants
Interval 7.3 to 14.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8Population: The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
SS1: Placebo
n=125 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=291 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
|
2.8 units on a scale
Interval 1.23 to 4.44
|
9.5 units on a scale
Interval 8.44 to 10.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52
|
14.5 percentage of participants
Interval 8.7 to 20.3
|
48.7 percentage of participants
Interval 40.5 to 56.8
|
61.6 percentage of participants
Interval 53.6 to 69.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Outcome measures
| Measure |
SS1: Placebo
n=54 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=58 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
|
22.2 percentage of participants
Interval 11.1 to 33.3
|
59.2 percentage of participants
Interval 45.1 to 73.4
|
69.7 percentage of participants
Interval 57.7 to 81.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.
Outcome measures
| Measure |
SS1: Placebo
n=54 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=58 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment
|
22.2 percentage of participants
Interval 11.1 to 33.3
|
57.1 percentage of participants
Interval 42.9 to 71.3
|
68.0 percentage of participants
Interval 55.8 to 80.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved endoscopic improvement in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=73 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=63 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=79 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment
|
19.2 percentage of participants
Interval 9.9 to 28.4
|
61.6 percentage of participants
Interval 49.6 to 73.7
|
69.5 percentage of participants
Interval 59.1 to 80.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52
|
5.6 percentage of participants
Interval 1.8 to 9.3
|
24.2 percentage of participants
Interval 17.3 to 31.2
|
25.9 percentage of participants
Interval 18.8 to 33.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical response per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).
Outcome measures
| Measure |
SS1: Placebo
n=134 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=135 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=144 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment
|
18.8 percentage of participants
Interval 12.1 to 25.5
|
63.0 percentage of participants
Interval 54.8 to 71.1
|
76.6 percentage of participants
Interval 69.6 to 83.6
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52
|
11.9 percentage of participants
Interval 6.7 to 17.2
|
35.0 percentage of participants
Interval 27.1 to 42.8
|
49.8 percentage of participants
Interval 41.5 to 58.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 52Population: Substudy 3 ITT\_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52
|
17.9 units on a scale
Interval 10.79 to 25.0
|
49.2 units on a scale
Interval 42.59 to 55.89
|
58.9 units on a scale
Interval 52.14 to 65.59
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52
|
4.7 percentage of participants
Interval 1.3 to 8.2
|
17.6 percentage of participants
Interval 11.4 to 23.8
|
19.0 percentage of participants
Interval 12.6 to 25.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Bowel urgency was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52
|
17.4 percentage of participants
Interval 11.4 to 23.5
|
56.1 percentage of participants
Interval 48.1 to 64.1
|
63.6 percentage of participants
Interval 56.0 to 71.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 52Population: Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.
Abdominal pain was assessed by participants in a subject diary completed once a day.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52
|
20.8 percentage of participants
Interval 14.2 to 27.3
|
45.9 percentage of participants
Interval 37.9 to 54.0
|
55.3 percentage of participants
Interval 47.4 to 63.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 52Population: Substudy 3 ITT\_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
SS1: Placebo
n=149 Participants
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=148 Participants
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=154 Participants
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
|---|---|---|---|---|---|
|
Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52
|
3.7 units on a scale
Interval 1.88 to 5.43
|
8.7 units on a scale
Interval 7.01 to 10.49
|
9.5 units on a scale
Interval 7.8 to 11.22
|
—
|
—
|
Adverse Events
SS1: Placebo
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
SS1: Upadacitinib 7.5 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
SS1: Upadacitinib 15 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
SS1: Upadacitinib 30 mg
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
SS1: Upadacitinib 45 mg
Serious events: 6 serious events
Other events: 50 other events
Deaths: 0 deaths
SS2: Placebo
Serious events: 9 serious events
Other events: 62 other events
Deaths: 0 deaths
SS2: Upadacitinib 45 mg
Serious events: 8 serious events
Other events: 121 other events
Deaths: 0 deaths
SS2: Placebo/Upadacitinib 45 mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
SS3: Placebo
Serious events: 32 serious events
Other events: 216 other events
Deaths: 0 deaths
SS3: Upadacitinib 7.5 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
SS3: Upadacitinib 15 mg
Serious events: 24 serious events
Other events: 181 other events
Deaths: 0 deaths
SS3: Upadacitinib 30 mg
Serious events: 25 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SS1: Placebo
n=46 participants at risk
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 participants at risk
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 participants at risk
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=117 participants at risk
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=123 participants at risk
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS2: Placebo
n=155 participants at risk
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS2: Upadacitinib 45 mg
n=319 participants at risk
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS2: Placebo/Upadacitinib 45 mg
n=85 participants at risk
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
n=59 participants at risk
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS3: Placebo
n=385 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
|
SS3: Upadacitinib 7.5 mg
n=20 participants at risk
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
|
SS3: Upadacitinib 15 mg
n=323 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
|
SS3: Upadacitinib 30 mg
n=316 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Eye disorders
CATARACT
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
4.3%
2/46 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
4/117 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.2%
5/155 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/319 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.3%
9/385 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.95%
3/316 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
COLON DYSPLASIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
DIAPHRAGMATIC HERNIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ILEUS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
General disorders
DEVICE INTOLERANCE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
General disorders
PYREXIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
ACUTE ENDOCARDITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
ANAL ABSCESS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/319 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
BREAST ABSCESS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
CELLULITIS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
HERPES ZOSTER MENINGITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
INFECTIOUS MONONUCLEOSIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
LARGE INTESTINE INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
MASTITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
MUSCLE ABSCESS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
PNEUMOCYSTIS JIROVECII PNEUMONIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
PNEUMONIA CRYPTOCOCCAL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
SINUSITIS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
PULMONARY CONTUSION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
CHONDROMALACIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL CARCINOMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
NONINFECTIVE BRONCHITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
PANNICULITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
Other adverse events
| Measure |
SS1: Placebo
n=46 participants at risk
During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 7.5 mg
n=47 participants at risk
During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 15 mg
n=49 participants at risk
During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS1: Upadacitinib 30 mg
n=117 participants at risk
During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS1: Upadacitinib 45 mg
n=123 participants at risk
During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.
|
SS2: Placebo
n=155 participants at risk
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS2: Upadacitinib 45 mg
n=319 participants at risk
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.
|
SS2: Placebo/Upadacitinib 45 mg
n=85 participants at risk
During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS2: Upadacitinib 45 mg/Upadacitinib 45 mg
n=59 participants at risk
During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.
|
SS3: Placebo
n=385 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.
|
SS3: Upadacitinib 7.5 mg
n=20 participants at risk
Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.
|
SS3: Upadacitinib 15 mg
n=323 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.
|
SS3: Upadacitinib 30 mg
n=316 participants at risk
Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.1%
3/49 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
4/117 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.8%
9/155 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/319 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.9%
5/85 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.2%
20/385 • Number of events 24 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
11/323 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.2%
7/316 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/319 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.93%
3/323 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Ear and labyrinth disorders
CERUMEN IMPACTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Eye disorders
CATARACT
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.4%
3/47 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
5/316 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/319 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
2/59 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
8/385 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/323 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
5/316 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
ABDOMINAL TENDERNESS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/319 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/316 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
8.7%
4/46 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.1%
2/49 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
4/117 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.3%
16/155 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
26.2%
101/385 • Number of events 110 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
15.0%
3/20 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
12.4%
40/323 • Number of events 47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
7.6%
24/316 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/319 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
4/323 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.2%
7/316 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
2/123 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.0%
4/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
NAUSEA
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.8%
8/117 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
3/155 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/319 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
6/385 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/323 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.2%
7/316 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
PERIANAL ERYTHEMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Gastrointestinal disorders
VOMITING
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/319 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.95%
3/316 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
General disorders
PSEUDOPOLYP
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
General disorders
PYREXIA
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.3%
5/117 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
2/155 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/319 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
7.1%
6/85 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.9%
11/385 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.1%
10/323 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.7%
18/316 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
BRONCHITIS
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.0%
4/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
4/323 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.93%
3/323 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
2/155 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.93%
3/323 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.95%
3/316 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.9%
5/85 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.1%
3/59 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.1%
10/323 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
15/316 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.0%
4/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.1%
10/323 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/316 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.1%
3/49 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
3/117 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.3%
4/123 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.9%
6/155 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
15/319 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
4/85 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
7.0%
27/385 • Number of events 28 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
9.6%
31/323 • Number of events 40 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
9.5%
30/316 • Number of events 43 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
ORAL HERPES
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/319 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.8%
7/385 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/323 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.8%
9/316 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
PULPITIS DENTAL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
4/323 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
SKIN CANDIDA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
8.2%
4/49 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
3/117 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.9%
6/123 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.9%
6/155 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/319 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.9%
11/385 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.9%
19/323 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
15/316 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
3/117 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
3/155 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.3%
9/385 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.1%
10/323 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/316 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.1%
2/49 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.3%
5/117 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.1%
3/49 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
4/117 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.5%
8/123 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
3/155 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
16/319 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.9%
5/85 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.8%
4/59 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.8%
7/385 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.2%
20/323 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.6%
21/316 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
2/123 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
3/155 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
2/123 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/323 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
5/316 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
4.3%
2/46 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
5/385 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.93%
3/323 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
2/155 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.3%
2/47 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
3/123 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.5%
7/155 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
5/319 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
7.3%
28/385 • Number of events 28 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
20.0%
4/20 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.9%
19/323 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/316 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.94%
3/319 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.9%
15/385 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
11/323 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/316 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
2/123 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.5%
3/46 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
2/123 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.0%
4/385 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/316 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/319 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Nervous system disorders
HEADACHE
|
10.9%
5/46 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
8.5%
4/47 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
8.2%
4/49 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
7.7%
9/117 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
6.5%
8/123 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
4/155 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.1%
13/319 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
4/85 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
2/59 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.2%
16/385 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.1%
10/323 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.4%
14/316 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.52%
2/385 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
3/117 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.3%
4/123 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
2/155 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
5/319 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
6/385 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/323 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/316 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.78%
3/385 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.1%
2/49 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.4%
4/117 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.9%
6/319 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
1/85 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.6%
6/385 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.5%
5/323 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/316 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/117 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
2/155 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/323 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.0%
1/49 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.1%
6/117 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.9%
6/123 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.7%
15/319 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.4%
2/85 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
8/385 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.2%
7/323 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.5%
11/316 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
2/117 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.3%
4/319 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/385 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/323 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/316 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.2%
1/46 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.6%
4/155 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.31%
1/319 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.3%
9/385 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.62%
2/323 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.63%
2/316 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.1%
1/47 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.3%
5/117 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.81%
1/123 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.65%
1/155 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.5%
8/319 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.7%
1/59 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
3.6%
14/385 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
10.0%
2/20 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
2.8%
9/323 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
4.4%
14/316 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.85%
1/117 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/123 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/155 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/319 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/85 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.00%
0/59 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.26%
1/385 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
5.0%
1/20 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
1.2%
4/323 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
0.32%
1/316 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER