Trial Outcomes & Findings for A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors (NCT NCT03184870)
NCT ID: NCT03184870
Last Updated: 2025-10-09
Results Overview
The number of participants who died within 100 days after receiving their last dose
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
332 participants
Primary outcome timeframe
From first dose up to 100 days post last dose, up to approximately 3 years
Results posted on
2025-10-09
Participant Flow
Two additional cohorts (Part 2-Arm D-Cohorts 7 and 8) with 300 mg BMS-813160 twice per day were planned according to a previous version of the protocol. However, these cohorts did not open for enrollment due to Cohort 4 being closed due to futility per Revised Protocol 06.
Participant milestones
| Measure |
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initial Treatment
STARTED
|
10
|
8
|
10
|
11
|
8
|
7
|
7
|
11
|
1
|
2
|
32
|
32
|
26
|
35
|
35
|
32
|
24
|
24
|
|
Initial Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Treatment
NOT COMPLETED
|
10
|
8
|
10
|
11
|
8
|
7
|
7
|
11
|
1
|
2
|
32
|
32
|
26
|
35
|
35
|
32
|
24
|
24
|
|
Crossover Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Crossover Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Crossover Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initial Treatment
Death
|
6
|
6
|
8
|
8
|
6
|
6
|
6
|
7
|
1
|
2
|
26
|
28
|
10
|
33
|
34
|
26
|
20
|
18
|
|
Initial Treatment
Other Reasons
|
2
|
2
|
0
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
4
|
2
|
2
|
0
|
0
|
1
|
0
|
2
|
|
Initial Treatment
Lost to Follow-up
|
2
|
0
|
0
|
1
|
1
|
1
|
0
|
2
|
0
|
0
|
2
|
0
|
2
|
2
|
0
|
0
|
2
|
2
|
|
Initial Treatment
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
1
|
5
|
2
|
2
|
|
Initial Treatment
Moved to crossover treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Crossover Treatment
Other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Crossover Treatment
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
Baseline Characteristics
9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
Baseline characteristics by cohort
| Measure |
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
All Cohorts except Part 2-Arm C-Cohort 5
|
65.6 Years
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
53.3 Years
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
64.1 Years
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
62.7 Years
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
59.5 Years
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
61.7 Years
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
45.1 Years
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
60.5 Years
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
61.0 Years
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
50.0 Years
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
55.0 Years
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
58.9 Years
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
57.9 Years
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
65.9 Years
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
65.3 Years
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
65.5 Years
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
63.9 Years
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
61.4 Years
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Age, Continuous
Part 2-Arm C-Cohort 5 only
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
55.0 Years
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
55.0 Years
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Sex: Female, Male
All Cohorts except Part 2-Arm C-Cohort 5 · Female
|
3 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
13 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
11 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
9 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
15 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
15 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
15 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
8 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
115 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Sex: Female, Male
All Cohorts except Part 2-Arm C-Cohort 5 · Male
|
7 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
5 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
8 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
19 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
21 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
17 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
20 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
20 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
17 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
16 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
176 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Sex: Female, Male
Part 2-Arm C-Cohort 5 only · Female
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
18 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
18 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Sex: Female, Male
Part 2-Arm C-Cohort 5 only · Male
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
15 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Hispanic or Latino
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
23 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Not Hispanic or Latino
|
8 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
5 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
8 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
9 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
8 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
21 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
26 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
17 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
28 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
30 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
24 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
21 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
227 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Unknown or Not Reported
|
2 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
5 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
41 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
|
—
|
4 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Not Hispanic or Latino
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
23 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
23 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Ethnicity (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Unknown or Not Reported
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
6 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · American Indian or Alaska Native
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
0 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Asian
|
1 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
17 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
0 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Black or African American
|
1 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
10 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · White
|
8 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
4 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
10 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
11 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
8 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
5 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
7 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
28 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
26 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
22 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
32 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
34 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
27 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
22 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
254 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · More than one race
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
0 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
All Cohorts except Part 2-Arm C-Cohort 5 · Unknown or Not Reported
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=10 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=8 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=7 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=11 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=1 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=2 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=26 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=35 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
2 Participants
n=32 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=24 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
—
|
10 Participants
n=291 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · American Indian or Alaska Native
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Asian
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Black or African American
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
3 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · White
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
28 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · More than one race
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
0 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
|
Race (NIH/OMB)
Part 2-Arm C-Cohort 5 only · Unknown or Not Reported
|
—
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—
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—
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—
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—
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—
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1 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
1 Participants
n=33 Participants • 9 participants crossed over from Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI to Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO. The baseline characteristics are broken into two rows to prevent double-counting and to make it the data associated with the cross over participants clear.
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
35 Participants
|
23 Participants
|
35 Participants
|
31 Participants
|
32 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
1 Participants
|
2 Participants
|
32 Participants
|
32 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
|
24 Participants
|
17 Participants
|
22 Participants
|
15 Participants
|
19 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
12 Participants
|
12 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants who completed the DLT evaluation period
Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants
An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
|
12 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants
The number of participants who died within 100 days after receiving their last dose
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
33 Participants
|
20 Participants
|
34 Participants
|
26 Participants
|
25 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
26 Participants
|
28 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants
The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Laboratory Abnormalities
Neutrophils (Absolute) (10^9/L) - Abnormal Low
|
22 Participants
|
1 Participants
|
25 Participants
|
25 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
25 Participants
|
20 Participants
|
18 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB (U/L) - Abnormal High
|
21 Participants
|
12 Participants
|
26 Participants
|
24 Participants
|
19 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB (U/L) - Abnormal High
|
24 Participants
|
10 Participants
|
28 Participants
|
24 Participants
|
13 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities
Total Bilirubin (UMOL/L) - Abnormal High
|
8 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities
PLATELET COUNT (10^9/L) - Abnormal Low
|
24 Participants
|
10 Participants
|
28 Participants
|
26 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
15 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose, up to approximately 3 yearsPopulation: All treated participants with vital sign measurements
Vital sign measurements at baseline and at the end of treatment. Baseline evaluations will be defined as evaluations with a date on or prior to the day of first dose of study treatment.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=21 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=15 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=24 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=16 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=24 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=1 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=3 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=5 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=3 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=10 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=1 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=9 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=9 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=5 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vital Signs
Systolic Blood Pressure (mmHg) - End of Treatment
|
123.2 mmHg
Standard Deviation 18.8
|
112.6 mmHg
Standard Deviation 11.6
|
128.9 mmHg
Standard Deviation 17.8
|
118.8 mmHg
Standard Deviation 15.9
|
123.1 mmHg
Standard Deviation 13.6
|
133.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
129.7 mmHg
Standard Deviation 6.7
|
130.2 mmHg
Standard Deviation 21.8
|
143.0 mmHg
Standard Deviation 34.0
|
114.0 mmHg
Standard Deviation 15.0
|
125.0 mmHg
Standard Deviation 6.1
|
140.3 mmHg
Standard Deviation 18.0
|
124.0 mmHg
Standard Deviation 23.7
|
151.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
107.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
126.0 mmHg
Standard Deviation 15.9
|
113.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
113.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
|
Vital Signs
Systolic Blood Pressure (mmHg) - Follow-up
|
119.2 mmHg
Standard Deviation 15.1
|
113.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
142.6 mmHg
Standard Deviation 16.0
|
108.3 mmHg
Standard Deviation 30.1
|
113.5 mmHg
Standard Deviation 6.4
|
140.0 mmHg
Standard Deviation 8.5
|
124.5 mmHg
Standard Deviation 2.1
|
100.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
143.0 mmHg
Standard Deviation 34.0
|
140.0 mmHg
Standard Deviation 8.5
|
108.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
148.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
129.5 mmHg
Standard Deviation 29.0
|
—
|
—
|
127.9 mmHg
Standard Deviation 13.2
|
131.3 mmHg
Standard Deviation 20.6
|
113.6 mmHg
Standard Deviation 8.1
|
|
Vital Signs
Diastolic Blood Pressure (mmHg) - End of Treatment
|
69.2 mmHg
Standard Deviation 8.2
|
68.1 mmHg
Standard Deviation 6.5
|
74.3 mmHg
Standard Deviation 8.6
|
70.2 mmHg
Standard Deviation 8.6
|
74.3 mmHg
Standard Deviation 9.7
|
83.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
73.3 mmHg
Standard Deviation 7.2
|
75.4 mmHg
Standard Deviation 12.4
|
80.8 mmHg
Standard Deviation 17.7
|
69.6 mmHg
Standard Deviation 9.4
|
86.0 mmHg
Standard Deviation 18.2
|
89.7 mmHg
Standard Deviation 11.1
|
74.3 mmHg
Standard Deviation 11.3
|
86.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
67.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
79.0 mmHg
Standard Deviation 11.5
|
74.5 mmHg
Standard Deviation 3.5
|
75.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
|
Vital Signs
Diastolic Blood Pressure (mmHg)- Follow-up
|
68.0 mmHg
Standard Deviation 9.9
|
85.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
70.2 mmHg
Standard Deviation 10.5
|
66.7 mmHg
Standard Deviation 20.1
|
69.0 mmHg
Standard Deviation 2.8
|
79.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
71.5 mmHg
Standard Deviation 14.8
|
59.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
85.0 mmHg
Standard Deviation 2.8
|
69.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
98.0 mmHg
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
72.5 mmHg
Standard Deviation 4.9
|
—
|
—
|
76.6 mmHg
Standard Deviation 14.6
|
76.1 mmHg
Standard Deviation 11.0
|
78.2 mmHg
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: From baseline up to 100 days post last dosePopulation: All treated participants with out-of-range ECGs
The number of participants with ECG measurements outside of the range pre-specified in the protocol.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=34 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=34 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=29 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=31 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=25 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
QTcF INTERVAL (MSEC) < 450
|
26 Participants
|
24 Participants
|
30 Participants
|
26 Participants
|
31 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
10 Participants
|
1 Participants
|
2 Participants
|
31 Participants
|
27 Participants
|
23 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
QTcF INTERVAL (MSEC): 450 <= QTcF < 480
|
6 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
480<=QTcF<500 (MSEC)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
QTcF>= 500 (MSEC)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
QTcB INTERVAL (MSEC) < 450
|
14 Participants
|
21 Participants
|
17 Participants
|
19 Participants
|
15 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
20 Participants
|
21 Participants
|
15 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
450<=QTcB<480 (MSEC)
|
14 Participants
|
3 Participants
|
14 Participants
|
8 Participants
|
18 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
480<=QTcB<500 (MSEC)
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Electrocardiograms (ECG)
QTcB>= 500 (MSEC)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)Population: All treated participants with immunohistochemistry data
The percent change in Regulatory T Cells (Treg) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=5 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=4 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=6 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=3 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=6 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=3 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=3 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=4 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=1 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=6 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=3 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=5 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C0D7
|
—
|
—
|
—
|
—
|
—
|
26.6 Percent change in Treg
Interval -67.0 to 180.0
|
-43.8 Percent change in Treg
Interval -58.0 to -15.0
|
-22.9 Percent change in Treg
Interval -74.0 to -14.0
|
156.4 Percent change in Treg
Interval -12.0 to 177.0
|
57.3 Percent change in Treg
Interval -76.0 to 116.0
|
-18.4 Percent change in Treg
Interval -27.0 to -9.0
|
-92.2 Percent change in Treg
Interval -94.0 to 27.0
|
96.4 Percent change in Treg
Interval 14.0 to 152.0
|
—
|
101.0 Percent change in Treg
Interval 101.0 to 101.0
|
—
|
—
|
—
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C0D14
|
—
|
—
|
—
|
—
|
—
|
26.5 Percent change in Treg
Interval -50.0 to 103.0
|
-19.8 Percent change in Treg
Interval -78.0 to 53.0
|
60.0 Percent change in Treg
Interval 60.0 to 60.0
|
-41.6 Percent change in Treg
Interval -67.0 to -16.0
|
-41 Percent change in Treg
Interval -41.0 to -41.0
|
-26.5 Percent change in Treg
Interval -57.0 to 249.0
|
180.2 Percent change in Treg
Interval -60.0 to 421.0
|
-3.7 Percent change in Treg
Interval -9.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C1D1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34.7 Percent change in Treg
Interval -58.0 to 128.0
|
49 Percent change in Treg
Interval 49.0 to 49.0
|
147.4 Percent change in Treg
Interval 20.0 to 275.0
|
33.0 Percent change in Treg
Interval -51.0 to 338.0
|
—
|
31.0 Percent change in Treg
Interval 31.0 to 31.0
|
—
|
—
|
—
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C1D15
|
113.6 Percent change in Treg
Interval -1.0 to 228.0
|
-64 Percent change in Treg
Interval -64.0 to -64.0
|
—
|
17.0 Percent change in Treg
Interval -39.0 to 73.0
|
—
|
—
|
—
|
—
|
—
|
-25.9 Percent change in Treg
Interval -48.0 to -6.0
|
14.5 Percent change in Treg
Interval -90.0 to 322.0
|
39.1 Percent change in Treg
Interval 4.0 to 74.0
|
-33 Percent change in Treg
Interval -33.0 to -33.0
|
—
|
—
|
—
|
-39.1 Percent change in Treg
Interval -46.0 to -32.0
|
60 Percent change in Treg
Interval 60.0 to 60.0
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C1D16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-21 Percent change in Treg
Interval -21.0 to -21.0
|
—
|
—
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C1D28
|
-36.0 Percent change in Treg
Interval -77.0 to -5.0
|
216.7 Percent change in Treg
Interval 98.0 to 363.0
|
99.4 Percent change in Treg
Interval -96.0 to 2199.0
|
-46.6 Percent change in Treg
Interval -55.0 to 551.0
|
-13.6 Percent change in Treg
Interval -78.0 to 149.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-7.4 Percent change in Treg
Interval -26.0 to 113.0
|
-77.0 Percent change in Treg
Interval -93.0 to -61.0
|
12.0 Percent change in Treg
Interval -73.0 to 152.0
|
|
Percent Change in Regulatory T Cells (Treg) in Tumor Samples
FOXP3 - C2D1
|
—
|
-2.4 Percent change in Treg
Interval -37.0 to 32.0
|
—
|
184 Percent change in Treg
Interval 184.0 to 184.0
|
156.2 Percent change in Treg
Interval 13.0 to 299.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
305.2 Percent change in Treg
Interval -73.0 to 683.0
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)Population: All treated participants with immunohistochemistry data
The percent change in Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=5 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=6 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=3 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=4 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=6 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=3 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=4 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C1D1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
477.5 Percent change in TAM
Interval 334.0 to 621.0
|
22.1 Percent change in TAM
Interval -28.0 to 520.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C1D15
|
145.7 Percent change in TAM
Interval 43.0 to 248.0
|
—
|
—
|
60.3 Percent change in TAM
Interval 1.0 to 120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.6 Percent change in TAM
Interval -37.0 to 53.0
|
-93 Percent change in TAM
Interval -93.0 to -93.0
|
—
|
—
|
—
|
89.8 Percent change in TAM
Interval 35.0 to 132.0
|
-61 Percent change in TAM
Interval -61.0 to -61.0
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C1D28
|
-14.7 Percent change in TAM
Interval -57.0 to 91.0
|
—
|
65.5 Percent change in TAM
Interval -31.0 to 666.0
|
1.0 Percent change in TAM
Interval -96.0 to 61.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-4.1 Percent change in TAM
Interval -21.0 to 1072.0
|
-58.4 Percent change in TAM
Interval -98.0 to -19.0
|
106.3 Percent change in TAM
Interval -67.0 to 511.0
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C0D14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
95.4 Percent change in TAM
Interval 34.0 to 157.0
|
133.6 Percent change in TAM
Interval 0.0 to 286.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C1D15
|
162.4 Percent change in TAM
Interval 150.0 to 175.0
|
—
|
—
|
92.5 Percent change in TAM
Interval 20.0 to 165.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.9 Percent change in TAM
Interval -26.0 to 185.0
|
-26 Percent change in TAM
Interval -26.0 to -26.0
|
—
|
—
|
—
|
-4.0 Percent change in TAM
Interval -27.0 to 58.0
|
81 Percent change in TAM
Interval 81.0 to 81.0
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C1D16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
272 Percent change in TAM
Interval 272.0 to 272.0
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C1D28
|
-38.3 Percent change in TAM
Interval -88.0 to 121.0
|
—
|
96.2 Percent change in TAM
Interval -25.0 to 179.0
|
-4.3 Percent change in TAM
Interval -46.0 to 102.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
31.5 Percent change in TAM
Interval -60.0 to 296.0
|
-70.7 Percent change in TAM
Interval -92.0 to -49.0
|
96.2 Percent change in TAM
Interval -50.0 to 1106.0
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C2D1
|
—
|
—
|
—
|
-40.0 Percent change in TAM
Interval -54.0 to -33.0
|
-66 Percent change in TAM
Interval -66.0 to -66.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-26.9 Percent change in TAM
Interval -50.0 to -4.0
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C0D7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.1 Percent change in TAM
Interval 2.0 to 808.0
|
-12.7 Percent change in TAM
Interval -67.0 to 231.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C1D16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1369 Percent change in TAM
Interval 1369.0 to 1369.0
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD163 Positive - C2D1
|
—
|
—
|
—
|
-41.3 Percent change in TAM
Interval -61.0 to -33.0
|
39.3 Percent change in TAM
Interval -1.0 to 79.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-58.3 Percent change in TAM
Interval -94.0 to -22.0
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C0D7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-70.2 Percent change in TAM
Interval -91.0 to 107.0
|
-17.1 Percent change in TAM
Interval -64.0 to -2.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C0D14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57.7 Percent change in TAM
Interval -12.0 to 128.0
|
7.9 Percent change in TAM
Interval -8.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples
CD68 Positive - C1D1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
294.2 Percent change in TAM
Interval 203.0 to 385.0
|
17.8 Percent change in TAM
Interval -39.0 to 102.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose until disease progression, or the last response recorded (up to approximately 5 years)Population: All treated participants
Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. Complete response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=24 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
22.9 Percent of participants
Interval 10.4 to 40.1
|
0 Percent of participants
Interval 0.0 to 14.2
|
17.1 Percent of participants
Interval 6.6 to 33.6
|
21.9 Percent of participants
Interval 9.3 to 40.0
|
8.3 Percent of participants
Interval 1.0 to 27.0
|
60.0 Percent of participants
Interval 26.2 to 87.8
|
25.0 Percent of participants
Interval 3.2 to 65.1
|
0 Percent of participants
Interval 0.0 to 30.8
|
18.2 Percent of participants
Interval 2.3 to 51.8
|
0 Percent of participants
Interval 0.0 to 36.9
|
0 Percent of participants
Interval 0.0 to 41.0
|
0 Percent of participants
Interval 0.0 to 41.0
|
0 Percent of participants
Interval 0.0 to 28.5
|
0 Percent of participants
Interval 0.0 to 97.5
|
0 Percent of participants
Interval 0.0 to 84.2
|
9.4 Percent of participants
Interval 2.0 to 25.0
|
9.4 Percent of participants
Interval 2.0 to 25.0
|
19.2 Percent of participants
Interval 6.6 to 39.4
|
PRIMARY outcome
Timeframe: From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)Population: All treated participants who achieved complete or partial response and were not censored
Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=7 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=6 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=7 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=6 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=2 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=2 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=3 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=3 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=5 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
32.14 Weeks
Interval 17.14 to 37.29
|
—
|
37.14 Weeks
Interval 14.14 to
Upper limit not calculated due to insufficient number of events
|
20.57 Weeks
Interval 14.29 to 31.0
|
NA Weeks
Interval 41.0 to
Median and upper limit not calculated due to insufficient number of events
|
159.00 Weeks
Interval 47.0 to
Upper limit not calculated due to insufficient number of events
|
NA Weeks
Interval 16.43 to
Median and upper limit not calculated due to insufficient number of events
|
—
|
NA Weeks
Interval 24.14 to
Median and upper limit not calculated due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
—
|
74.14 Weeks
Interval 32.14 to
Upper limit not calculated due to insufficient number of events
|
56.57 Weeks
Interval 40.17 to
Upper limit not calculated due to insufficient number of events
|
36.21 Weeks
Interval 16.14 to
Upper limit not calculated due to insufficient number of events
|
PRIMARY outcome
Timeframe: From first dose up to Week 24Population: All treated participants who were assessed for progression free survival at Week 24
PFS rate is defined as the proportion of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to \< 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions. Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=17 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=21 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=13 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=3 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=5 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=6 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=1 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=7 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=14 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=13 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Rate at 24 Weeks
|
0.535 Proportion of Participants
Interval 0.3512 to 0.6888
|
—
|
0.636 Proportion of Participants
Interval 0.4495 to 0.7746
|
0.467 Proportion of Participants
Interval 0.2779 to 0.6358
|
NA Proportion of Participants
Not calculated due to insufficient number of participants who reached threshold
|
0.778 Proportion of Participants
Interval 0.3648 to 0.9393
|
NA Proportion of Participants
Not calculated due to insufficient number of participants who reached threshold
|
0.556 Proportion of Participants
Interval 0.2042 to 0.8045
|
0.800 Proportion of Participants
Interval 0.4087 to 0.9459
|
—
|
—
|
—
|
NA Proportion of Participants
Not calculated due to insufficient number of participants who reached threshold
|
—
|
—
|
0.357 Proportion of Participants
Interval 0.1699 to 0.549
|
0.536 Proportion of Participants
Interval 0.3372 to 0.6996
|
0.691 Proportion of Participants
Interval 0.4361 to 0.8478
|
SECONDARY outcome
Timeframe: From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=20 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=18 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=15 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximim Concentration (Cmax)
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
620.4 ng/mL
Standard Deviation 250.60
|
2204.1 ng/mL
Standard Deviation 961.90
|
828.4 ng/mL
Standard Deviation 458.03
|
2419.0 ng/mL
Standard Deviation 1203.53
|
486.3 ng/mL
Standard Deviation 137.69
|
1896.3 ng/mL
Standard Deviation 1421.89
|
1179.1 ng/mL
Standard Deviation 605.50
|
276.28 ng/mL
Standard Deviation 141.915
|
1580.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
807.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Maximim Concentration (Cmax)
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
172.23 ng/mL
Standard Deviation 103.837
|
435.6 ng/mL
Standard Deviation 284.14
|
207.63 ng/mL
Standard Deviation 142.559
|
545.7 ng/mL
Standard Deviation 218.89
|
92.33 ng/mL
Standard Deviation 50.015
|
539.1 ng/mL
Standard Deviation 465.93
|
237.63 ng/mL
Standard Deviation 188.286
|
54.82 ng/mL
Standard Deviation 23.716
|
504.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
72.50 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Maximim Concentration (Cmax)
C0D14 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
927.1 ng/mL
Standard Deviation 513.88
|
4152.5 ng/mL
Standard Deviation 2010.23
|
1060.3 ng/mL
Standard Deviation 830.04
|
3274.0 ng/mL
Standard Deviation 884.15
|
701.5 ng/mL
Standard Deviation 284.59
|
1793.5 ng/mL
Standard Deviation 1607.25
|
653.3 ng/mL
Standard Deviation 298.08
|
80.00 ng/mL
Standard Deviation 19.408
|
1370.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
1680.0 ng/mL
Standard Deviation 961.67
|
—
|
—
|
—
|
|
Maximim Concentration (Cmax)
C0D14 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
317.90 ng/mL
Standard Deviation 290.209
|
658.3 ng/mL
Standard Deviation 143.17
|
409.63 ng/mL
Standard Deviation 382.471
|
792.2 ng/mL
Standard Deviation 503.92
|
183.08 ng/mL
Standard Deviation 190.050
|
326.0 ng/mL
Standard Deviation 241.83
|
165.83 ng/mL
Standard Deviation 92.914
|
25.307 ng/mL
Standard Deviation 16.6021
|
498.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
265.40 ng/mL
Standard Deviation 235.608
|
—
|
—
|
—
|
|
Maximim Concentration (Cmax)
C2D1 - BMS-813160
|
796.2 ng/mL
Standard Deviation 472.48
|
—
|
—
|
—
|
—
|
1153.1 ng/mL
Standard Deviation 617.97
|
3280.0 ng/mL
Standard Deviation 777.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
903.9 ng/mL
Standard Deviation 578.56
|
357.55 ng/mL
Standard Deviation 264.384
|
—
|
|
Maximim Concentration (Cmax)
C2D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
254.1 ng/mL
Standard Deviation 140.73
|
571.0 ng/mL
Standard Deviation 376.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Tmax is defined as the time in hours of the maximum observed plasma concentration
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=20 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=18 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=15 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax)
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
2.000 Hours
Interval 0.5 to 4.0
|
0.500 Hours
Interval 0.47 to 4.0
|
3.017 Hours
Interval 2.0 to 4.02
|
2.492 Hours
Interval 0.73 to 5.98
|
2.492 Hours
Interval 0.52 to 11.92
|
2.983 Hours
Interval 0.58 to 8.92
|
3.00 Hours
Interval 0.5 to 6.0
|
1.992 Hours
Interval 0.5 to 3.0
|
2.0 Hours
Interval 2.0 to 2.0
|
3.950 Hours
Interval 3.95 to 3.95
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax)
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
3.500 Hours
Interval 0.5 to 6.25
|
1.000 Hours
Interval 0.5 to 4.0
|
3.508 Hours
Interval 1.0 to 11.98
|
3.000 Hours
Interval 0.73 to 5.98
|
3.000 Hours
Interval 1.0 to 11.92
|
2.083 Hours
Interval 1.08 to 8.92
|
3.000 Hours
Interval 1.0 to 6.0
|
2.000 Hours
Interval 0.98 to 4.0
|
2.0 Hours
Interval 2.0 to 2.0
|
1.950 Hours
Interval 1.95 to 1.95
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax)
C0D14 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
3.000 Hours
Interval 0.55 to 3.03
|
1.825 Hours
Interval 0.5 to 3.0
|
2.917 Hours
Interval 0.92 to 15.7
|
2.983 Hours
Interval 0.5 to 4.0
|
2.875 Hours
Interval 0.5 to 3.0
|
2.0 Hours
Interval 1.0 to 3.0
|
2.000 Hours
Interval 1.0 to 3.02
|
1.00 Hours
Interval 0.5 to 4.0
|
2.02 Hours
Interval 2.02 to 2.02
|
2.542 Hours
Interval 2.0 to 3.08
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax)
C0D14 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
3.000 Hours
Interval 0.98 to 4.0
|
1.825 Hours
Interval 0.5 to 3.0
|
3.000 Hours
Interval 1.08 to 15.7
|
2.983 Hours
Interval 1.0 to 4.0
|
2.875 Hours
Interval 1.17 to 3.0
|
2.492 Hours
Interval 1.98 to 3.0
|
3.000 Hours
Interval 1.0 to 4.02
|
1.0 Hours
Interval 1.0 to 6.0
|
2.02 Hours
Interval 2.02 to 2.02
|
3.117 Hours
Interval 2.0 to 4.23
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax)
C2D1 - BMS-813160
|
3.992 Hours
Interval 0.5 to 16.17
|
—
|
—
|
—
|
—
|
3.000 Hours
Interval 0.98 to 4.23
|
1.000 Hours
Interval 0.47 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.033 Hours
Interval 0.5 to 14.1
|
2.067 Hours
Interval 0.5 to 8.1
|
—
|
|
Time to Maximum Concentration (Tmax)
C2D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
3.000 Hours
Interval 2.0 to 4.23
|
1.000 Hours
Interval 0.97 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=7 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=6 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=1 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=6 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=3 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=4 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=1 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=11 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=16 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=3 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Trough Observed Plasma Concentration (Ctrough)
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
283.70 ng/mL
Standard Deviation 207.784
|
84.30 ng/mL
Standard Deviation 46.169
|
292.0 ng/mL
Standard Deviation 154.31
|
74.05 ng/mL
Standard Deviation 72.127
|
157.28 ng/mL
Standard Deviation 92.311
|
137.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
57.10 ng/mL
Standard Deviation 54.871
|
5.485 ng/mL
Standard Deviation 2.4395
|
77.40 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
154.05 ng/mL
Standard Deviation 139.936
|
—
|
—
|
—
|
|
Trough Observed Plasma Concentration (Ctrough)
C5D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
268.80 ng/mL
Standard Deviation 216.882
|
129.40 ng/mL
Standard Deviation 89.944
|
176.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
15.30 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
323.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Observed Plasma Concentration (Ctrough)
C5D1 - BMS-939429
|
191.44 ng/mL
Standard Deviation 113.725
|
—
|
222.65 ng/mL
Standard Deviation 154.316
|
—
|
390.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
55.78 ng/mL
Standard Deviation 31.877
|
15.95 ng/mL
Standard Deviation 4.172
|
155.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
10.50 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
65.20 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
—
|
—
|
186.21 ng/mL
Standard Deviation 131.457
|
12.439 ng/mL
Standard Deviation 6.9685
|
195.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
|
Trough Observed Plasma Concentration (Ctrough)
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
172.63 ng/mL
Standard Deviation 264.187
|
31.40 ng/mL
Standard Deviation 10.689
|
180.88 ng/mL
Standard Deviation 195.959
|
72.95 ng/mL
Standard Deviation 55.542
|
47.60 ng/mL
Standard Deviation 10.412
|
31.50 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
63.45 ng/mL
Standard Deviation 60.175
|
4.950 ng/mL
Standard Deviation 2.3052
|
90.30 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
71.65 ng/mL
Standard Deviation 55.649
|
—
|
—
|
—
|
|
Trough Observed Plasma Concentration (Ctrough)
C1D15 - BMS 939429
|
116.04 ng/mL
Standard Deviation 29.696
|
283.0 ng/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
145.00 ng/mL
Standard Deviation 99.293
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
191.33 ng/mL
Standard Deviation 84.266
|
24.106 ng/mL
Standard Deviation 18.445
|
275.7 ng/mL
Standard Deviation 164.34
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints- C0D1, C2D1Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=14 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=1 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=9 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=13 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under Curve (AUC) 0-8
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
2300.018 ug*h/mL
Standard Deviation 976.4608
|
7069.265 ug*h/mL
Standard Deviation 2452.4213
|
2725.390 ug*h/mL
Standard Deviation 1365.3562
|
7884.381 ug*h/mL
Standard Deviation 3968.4940
|
1534.932 ug*h/mL
Standard Deviation 518.2172
|
6593.904 ug*h/mL
Standard Deviation 3603.5286
|
3533.737 ug*h/mL
Standard Deviation 1931.7752
|
878.051 ug*h/mL
Standard Deviation 535.3197
|
4440.313 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
3656.713 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Area Under Curve (AUC) 0-8
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
652.848 ug*h/mL
Standard Deviation 363.5925
|
1783.336 ug*h/mL
Standard Deviation 856.0103
|
936.394 ug*h/mL
Standard Deviation 826.5807
|
2302.092 ug*h/mL
Standard Deviation 1023.3978
|
342.534 ug*h/mL
Standard Deviation 157.1350
|
2147.888 ug*h/mL
Standard Deviation 1415.6386
|
942.398 ug*h/mL
Standard Deviation 620.1018
|
210.938 ug*h/mL
Standard Deviation 106.5352
|
1919.228 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
411.410 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Area Under Curve (AUC) 0-8
C2D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
1410.415 ug*h/mL
Standard Deviation 837.4895
|
2403.182 ug*h/mL
Standard Deviation 1144.3271
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under Curve (AUC) 0-8
C2D1 - BMS-813160
|
3821.887 ug*h/mL
Standard Deviation 2221.2474
|
—
|
—
|
—
|
—
|
5348.973 ug*h/mL
Standard Deviation 2506.2558
|
11967.560 ug*h/mL
Standard Deviation 4586.3823
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4838.264 ug*h/mL
Standard Deviation 2750.7756
|
1483.423 ug*h/mL
Standard Deviation 1236.0374
|
—
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints-C0D1, C2D1Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=9 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=1 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=11 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under Curve (AUC) 0-24
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
—
|
9383.385 ug*h/mL
Standard Deviation 2842.8397
|
—
|
11726.669 ug*h/mL
Standard Deviation 6439.1376
|
—
|
10447.179 ug*h/mL
Standard Deviation 2995.9347
|
4829.881 ug*h/mL
Standard Deviation 2696.4668
|
1275.314 ug*h/mL
Standard Deviation 799.8262
|
—
|
7687.658 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Area Under Curve (AUC) 0-24
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
—
|
2638.062 ug*h/mL
Standard Deviation 977.2502
|
—
|
3991.522 ug*h/mL
Standard Deviation 1636.3573
|
—
|
3905.941 ug*h/mL
Standard Deviation 1852.8415
|
1660.159 ug*h/mL
Standard Deviation 991.0121
|
341.0396 ug*h/mL
Standard Deviation 160.4425
|
—
|
940.294 ug*h/mL
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
—
|
—
|
—
|
|
Area Under Curve (AUC) 0-24
C2D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
—
|
17890.458 ug*h/mL
Standard Deviation 9212.5646
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2050.804 ug*h/mL
Standard Deviation 997.6990
|
—
|
|
Area Under Curve (AUC) 0-24
C2D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
—
|
3958.779 ug*h/mL
Standard Deviation 1632.3781
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints-C0D1, C2D14Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=5 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=7 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=6 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=3 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=2 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=9 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=13 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Body Clearance (CLT/F)
C0D14 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
1163.173 mL/min
Standard Deviation 588.1385
|
744.746 mL/min
Standard Deviation 361.5390
|
1521.863 mL/min
Standard Deviation 1277.8075
|
826.468 mL/min
Standard Deviation 300.1738
|
1602.009 mL/min
Standard Deviation 1123.8919
|
961.379 mL/min
Standard Deviation 235.4622
|
1688.813 mL/min
Standard Deviation 1022.7160
|
4950.110 mL/min
Standard Deviation 781.0155
|
1135.947 mL/min
Standard Deviation NA
Standard deviation not calculated due to insufficient number of events
|
1032.434 mL/min
Standard Deviation 850.2203
|
—
|
—
|
—
|
|
Apparent Total Body Clearance (CLT/F)
C2D1 - BMS-813160
|
1440.516 mL/min
Standard Deviation 733.5156
|
—
|
—
|
—
|
—
|
956.446 mL/min
Standard Deviation 596.7553
|
683.958 mL/min
Standard Deviation 322.7045
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1115.087 mL/min
Standard Deviation 851.2513
|
1813.987 mL/min
Standard Deviation 1920.2627
|
—
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints-C0D1, C0D14Population: Pharmacokinetic evaluable participants - all participants who received at least one dose of medicine and have corresponding evaluable plasma or serum concentration data.
Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=7 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=4 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=6 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=3 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=3 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=5 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=4 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=1 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLR)
C0D1 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
74.298 mL/min
Standard Deviation 44.8889
|
175.109 mL/min
Standard Deviation 187.5683
|
68.184 mL/min
Standard Deviation 52.1580
|
77.744 mL/min
Standard Deviation 34.8177
|
81.027 mL/min
Standard Deviation 65.1050
|
98.733 mL/min
Standard Deviation 6.2562
|
140.597 mL/min
Standard Deviation 41.7347
|
128.943 mL/min
Standard Deviation 26.7782
|
—
|
62.007 mL/min
|
—
|
—
|
—
|
|
Renal Clearance (CLR)
C0D14 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
185.926 mL/min
Standard Deviation 56.5866
|
124.400 mL/min
Standard Deviation 52.1454
|
260.786 mL/min
Standard Deviation 120.8954
|
168.274 mL/min
Standard Deviation 72.7581
|
158.238 mL/min
Standard Deviation 82.5905
|
194.009 mL/min
Standard Deviation 50.1111
|
283.842 mL/min
Standard Deviation 109.4518
|
149.271 mL/min
Standard Deviation 72.0204
|
—
|
115.147 mL/min
|
—
|
—
|
—
|
|
Renal Clearance (CLR)
C0D14 - BMS-939429
|
—
|
—
|
—
|
—
|
—
|
101.042 mL/min
Standard Deviation 27.5043
|
76.285 mL/min
Standard Deviation 30.5071
|
145.662 mL/min
Standard Deviation 73.3215
|
91.490 mL/min
Standard Deviation 43.8006
|
87.068 mL/min
Standard Deviation 43.9667
|
111.649 mL/min
Standard Deviation 32.4552
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Renal Clearance (CLR)
C0D1 - BMS-813160
|
—
|
—
|
—
|
—
|
—
|
212.411 mL/min
Standard Deviation 191.8961
|
275.309 mL/min
Standard Deviation 277.2659
|
139.012 mL/min
Standard Deviation 107.2006
|
165.327 mL/min
Standard Deviation 77.8766
|
155.820 mL/min
Standard Deviation 119.3858
|
181.930 mL/min
Standard Deviation 9.1130
|
248.003 mL/min
Standard Deviation 82.6974
|
236.781 mL/min
Standard Deviation 62.8689
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1Population: All treated participants with baseline measurements and at least one positive ADA assessment of Nivolumab
The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.
Outcome measures
| Measure |
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 Participants
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 Participants
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 Participants
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 Participants
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 Participants
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 Participants
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 Participants
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 Participants
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 Participants
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 Participants
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 Participants
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 Participants
Second-line treatment FOLFIRI in participants with colorectal cancer.
9 of the 26 participants who originated in this arm crossed over to Cohort 5.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Anti-Drug Antibody (ADA) Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR
Serious events: 5 serious events
Other events: 10 other events
Deaths: 6 deaths
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
Serious events: 5 serious events
Other events: 9 other events
Deaths: 8 deaths
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
Serious events: 7 serious events
Other events: 11 other events
Deaths: 8 deaths
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
Serious events: 6 serious events
Other events: 7 other events
Deaths: 6 deaths
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
Serious events: 6 serious events
Other events: 7 other events
Deaths: 6 deaths
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
Serious events: 6 serious events
Other events: 10 other events
Deaths: 7 deaths
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
Serious events: 12 serious events
Other events: 32 other events
Deaths: 26 deaths
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
Serious events: 12 serious events
Other events: 31 other events
Deaths: 28 deaths
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
Serious events: 6 serious events
Other events: 25 other events
Deaths: 17 deaths
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
Serious events: 24 serious events
Other events: 35 other events
Deaths: 33 deaths
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
Serious events: 22 serious events
Other events: 34 other events
Deaths: 34 deaths
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
Serious events: 15 serious events
Other events: 31 other events
Deaths: 26 deaths
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
Serious events: 17 serious events
Other events: 19 other events
Deaths: 20 deaths
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
Serious events: 19 serious events
Other events: 30 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR
n=10 participants at risk
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 participants at risk
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 participants at risk
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 participants at risk
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 participants at risk
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 participants at risk
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 participants at risk
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 participants at risk
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 participants at risk
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 participants at risk
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 participants at risk
Second-line treatment FOLFIRI in participants with colorectal cancer.
|
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 participants at risk
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 participants at risk
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 participants at risk
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 participants at risk
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Death
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
General physical health deterioration
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Gastroenteritis sapovirus
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Hepatic infection
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Splenic infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Wrong product administered
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
White blood cell count increased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Histiocytic necrotising lymphadenitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
71.4%
5/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
36.4%
4/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
2/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
29.2%
7/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
24.2%
8/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
Other adverse events
| Measure |
Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIR
n=10 participants at risk
First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
n=8 participants at risk
First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
|
Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
n=10 participants at risk
First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
|
Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
n=11 participants at risk
First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
|
Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
n=8 participants at risk
Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO
n=7 participants at risk
Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO
n=7 participants at risk
Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
n=11 participants at risk
Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
n=1 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
n=2 participants at risk
Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
n=32 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
n=32 participants at risk
Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
|
Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
n=26 participants at risk
Second-line treatment FOLFIRI in participants with colorectal cancer.
|
Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
n=35 participants at risk
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
n=35 participants at risk
First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
|
Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
n=32 participants at risk
First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
n=24 participants at risk
Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
|
Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
n=33 participants at risk
Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
60.0%
6/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
70.0%
7/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.5%
5/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
62.5%
5/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
36.4%
4/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.6%
13/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
34.4%
11/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
57.7%
15/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
65.7%
23/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
77.1%
27/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
59.4%
19/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
41.7%
10/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
9/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.4%
4/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Generalised oedema
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Cyst
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
4/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
5/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.5%
5/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
19.2%
5/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
60.0%
21/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
57.1%
20/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
62.5%
20/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
29.2%
7/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
6/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
8/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.1%
9/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
26.9%
7/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
34.3%
12/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Photophobia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Photopsia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
16.7%
4/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.0%
4/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.1%
13/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
8/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
24.2%
8/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Anal rash
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
5/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.6%
13/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.8%
8/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.7%
16/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
15/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
12/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
16.7%
4/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Diarrhoea
|
70.0%
7/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.6%
13/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
43.8%
14/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
57.7%
15/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
15/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
54.3%
19/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.6%
13/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
6/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
24.2%
8/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Faeces discoloured
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Lip pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
75.0%
6/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.0%
4/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
63.6%
7/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
57.1%
4/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
12/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
12/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
46.2%
12/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
65.7%
23/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
60.0%
21/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
43.8%
14/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
9/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
6/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
19.2%
5/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
40.0%
4/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
71.4%
5/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.8%
8/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.1%
9/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Asthenia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Chills
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Localised oedema
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Malaise
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Mucosal inflammation
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.4%
4/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.5%
5/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
15/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
34.3%
12/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
34.4%
11/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
15/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
6/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
General disorders
Temperature intolerance
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Hepatic pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Anorectal infection
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Diverticulitis
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Paronychia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Pyuria
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Rash pustular
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Injury, poisoning and procedural complications
Vascular access site rash
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
36.4%
4/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Amylase increased
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.1%
9/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.2%
7/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.1%
9/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
29.2%
7/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Blood creatinine increased
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
International normalised ratio increased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Lipase increased
|
40.0%
4/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
16.7%
4/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
36.4%
4/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
43.8%
14/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
8/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.8%
8/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
46.9%
15/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Platelet count decreased
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.1%
9/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Investigations
White blood cell count decreased
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.5%
5/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.4%
4/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
48.6%
17/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
45.7%
16/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
12/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
29.2%
7/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.3%
10/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
29.2%
7/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.8%
5/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
36.4%
4/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
48.6%
17/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
8/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
16.7%
4/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Burning sensation
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Dizziness
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Neuropathy peripheral
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
17.1%
6/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Confusional state
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.3%
2/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.6%
5/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.2%
5/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
10/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.8%
6/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
3/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
3/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.4%
4/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
100.0%
1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
3/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
62.5%
5/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.2%
10/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
21.9%
7/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
15.4%
4/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.1%
13/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
31.4%
11/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
12/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
18.2%
2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.8%
1/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
5/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
2/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.5%
3/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
25.7%
9/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
37.1%
13/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.4%
3/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.1%
2/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
20.0%
7/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
22.9%
8/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.1%
4/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
5.7%
2/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
9.1%
1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
2.9%
1/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.0%
1/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
6.2%
2/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
7.7%
2/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
27.3%
3/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
3.1%
1/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
11.4%
4/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
8.6%
3/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
4/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
4.2%
1/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
10.0%
1/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/10 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/26 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/35 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/32 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/24 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
0.00%
0/33 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
The 9 crossover participants are counted in the arm in which they experienced the adverse event.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER